Report Sections

See All Reports

Coronavirus Infections (722) Severe Acute Respiratory Syndrome (493) Infection (402) Pneumonia (331) Communicable Diseases (176) Respiratory Distress Syndrome, Adult (161) Acute Lung Injury (126) Respiratory Distress Syndrome, Newborn (126) (114) Syndrome (106) Virus Diseases (85) Pneumonia, Viral (73) Critical Illness (63) Depression (62) Anxiety Disorders (44) Disease (39) Stress Disorders, Post-Traumatic (34) Emergencies (31) Respiratory Tract Infections (31) Inflammation (30) Neoplasms (30) Cardiovascular Diseases (29) Stress Disorders, Traumatic (29) Wounds and Injuries (29) Lung Injury (27) Stress, Psychological (27) Mental Disorders (26) Diabetes Mellitus (25) Hypoxia (25) Depressive Disorder (24) Thrombosis (23) Hypertension (22) Respiratory Tract Diseases (22) Acute Kidney Injury (21) Lung Diseases (21) Disease Progression (18) Olfaction Disorders (18) Embolism (16) Influenza, Human (16) Stroke (16) Arthritis (15) Pulmonary Embolism (15) Respiration Disorders (15) Blood Coagulation Disorders (14) HIV Infections (14) Hemostatic Disorders (14) Thromboembolism (14) Burnout, Psychological (13) Chronic Disease (13) Fibrosis (13) Lung Diseases, Obstructive (13) Multiple Sclerosis (13) Sclerosis (13) Cognitive Dysfunction (12) Diabetes Mellitus, Type 2 (12) Lung Diseases, Interstitial (12) Myocardial Infarction (12) Pulmonary Disease, Chronic Obstructive (12) Pulmonary Fibrosis (12) Respiratory Aspiration (12) Arthritis, Rheumatoid (11) Autism Spectrum Disorder (11) Brain Injuries (11) Chronic Pain (11) Heart Diseases (11) Kidney Diseases (11) Substance-Related Disorders (11) Venous Thrombosis (11) Crohn Disease (10) Diabetes Mellitus, Type 1 (10) Heart Failure (10) Infarction (10) Lung Neoplasms (10) Autistic Disorder (9) Dyspnea (9) Myocarditis (9) Obesity (9) Pneumonia, Ventilator-Associated (9) Pregnancy Complications (9) Brain Injuries, Traumatic (8) Carcinoma (8) Colitis (8) Colitis, Ulcerative (8) Depression, Postpartum (8) Liver Diseases (8) Renal Insufficiency, Chronic (8) Respiratory Syncytial Virus Infections (8) Rheumatic Diseases (8) Ulcer (8) Vitamin D Deficiency (8) Coronary Artery Disease (7) Coronary Disease (7) Dementia (7) Feeding and Eating Disorders (7) Hematologic Neoplasms (7) Infertility (7) Inflammatory Bowel Diseases (7) Kidney Failure, Chronic (7) Parkinson Disease (7) Problem Behavior (7) Pulmonary Valve Insufficiency (7) Venous Thromboembolism (7) Burnout, Professional (6) Collagen Diseases (6) Frailty (6) Immune System Diseases (6) Immunologic Deficiency Syndromes (6) Ischemia (6) Lupus Erythematosus, Systemic (6) Lymphoma (6) Musculoskeletal Pain (6) Overweight (6) Parasomnias (6) Pediatric Obesity (6) Psychotic Disorders (6) RNA Virus Infections (6) Sepsis (6) Shock (6) Spinal Cord Injuries (6) Acute Coronary Syndrome (5) Alcohol Drinking (5) Alcoholism (5) Autoimmune Diseases (5) Breast Neoplasms (5) Carcinoma, Non-Small-Cell Lung (5) Child Development Disorders, Pervasive (5) Convalescence (5) Coronaviridae Infections (5) Cystic Fibrosis (5) Delirium (5) Depressive Disorder, Major (5) Disease Susceptibility (5) Dyssomnias (5) Gastroparesis (5) Hypersensitivity (5) Leukemia (5) Lymphopenia (5) Multiple Organ Failure (5) Myocardial Ischemia (5) Neurologic Manifestations (5) Osteoarthritis (5) Prostatic Neoplasms (5) Renal Insufficiency (5) Alzheimer Disease (4) Asthma (4) Attention Deficit Disorder with Hyperactivity (4) Behavior, Addictive (4) Body Weight (4) Brain Diseases (4) Coinfection (4) Colonic Neoplasms (4) Death (4) Deglutition Disorders (4) Disseminated Intravascular Coagulation (4) Embolism and Thrombosis (4) Fibromyalgia (4) Head and Neck Neoplasms (4) Heart Arrest (4) Hemorrhage (4) Hypertension, Pulmonary (4) Liver Cirrhosis (4) Metabolic Syndrome (4) Migraine Disorders (4) Mycobacterium Infections (4) Neoplasm Metastasis (4) (4) Pancreatic Neoplasms (4) Postoperative Complications (4) Prediabetic State (4) Signs and Symptoms, Respiratory (4) Sjogren's Syndrome (4) Sleep Apnea Syndromes (4) Sleep Initiation and Maintenance Disorders (4) Thrombophilia (4) Vascular Diseases (4) Weight Loss (4) Acquired Immunodeficiency Syndrome (3) Adenoviridae Infections (3) Appendicitis (3) Arrhythmias, Cardiac (3) Arthritis, Psoriatic (3) Asymptomatic Diseases (3) Bronchiectasis (3) Carcinoma, Renal Cell (3) Cardiomyopathies (3) Chilblains (3) Common Cold (3) Cross Infection (3) Dermatitis (3) Developmental Disabilities (3) Digestive System Diseases (3) Dysgeusia (3) Endometriosis (3) Fatigue (3) Fever (3) Gastrointestinal Diseases (3) Giant Cell Arteritis (3) Glucose Intolerance (3) Glucose Metabolism Disorders (3) Hemophilia A (3) Leukemia, Lymphoid (3) Macular Edema (3) Malnutrition (3) Measles (3) Melanoma (3) Metabolic Diseases (3) Mucocutaneous Lymph Node Syndrome (3) (3) Nervous System Diseases (3) Neuroendocrine Tumors (3) Occupational Stress (3) Osteoarthritis, Knee (3) Ovarian Neoplasms (3) Panic Disorder (3) Paramyxoviridae Infections (3) Peripheral Arterial Disease (3) Polymyalgia Rheumatica (3) Precursor Cell Lymphoblastic Leukemia-Lymphoma (3) Pregnancy Complications, Infectious (3) Premature Birth (3) Psychological Trauma (3) Pulmonary Edema (3) Rheumatic Fever (3) ST Elevation Myocardial Infarction (3) Schizophrenia (3) Seizures (3) Sleep Apnea, Obstructive (3) Sleep Wake Disorders (3) Systemic Inflammatory Response Syndrome (3) Taste Disorders (3) Tobacco Use Disorder (3) Triple Negative Breast Neoplasms (3) Ventricular Dysfunction (3) Ventricular Dysfunction, Left (3) Acute Disease (2) Ageusia (2) Agoraphobia (2) Alopecia (2) Alpha 1-Antitrypsin Deficiency (2) Amyotrophic Lateral Sclerosis (2) Anemia, Sickle Cell (2) Angina Pectoris (2) Angioedema (2) Angioedemas, Hereditary (2) Anxiety, Separation (2) Arteritis (2) Asymptomatic Infections (2) Atherosclerosis (2) Atrial Fibrillation (2) Bacterial Infections (2) Behcet Syndrome (2) Bipolar Disorder (2) Caliciviridae Infections (2) Clinical Deterioration (2) Cognition Disorders (2) Colorectal Neoplasms (2) Communicable Diseases, Emerging (2) Compassion Fatigue (2) Compulsive Personality Disorder (2) Congenital Abnormalities (2) Conjunctivitis (2) Dermatitis, Atopic (2) Diarrhea (2) Drug-Related Side Effects and Adverse Reactions (2) Eczema (2) Emphysema (2) Endocrine System Diseases (2) Fatigue Syndrome, Chronic (2) Ganglion Cysts (2) Gastroenteritis (2) Gastroesophageal Reflux (2) Gaucher Disease (2) Glioblastoma (2) Headache (2) Healthcare-Associated Pneumonia (2) Heart Defects, Congenital (2) Heart Failure, Systolic (2) Hematologic Diseases (2) Huntington Disease (2) Hyperglycemia (2) Hyperkinesis (2) Hyperphagia (2) Hypothermia (2) Hypoventilation (2) Idiopathic Pulmonary Fibrosis (2) Intervertebral Disc Degeneration (2) Intestinal Diseases (2) Ischemic Attack, Transient (2) Jaundice (2) Leukemia, Myeloid, Acute (2) Lymphoproliferative Disorders (2) Macular Degeneration (2) Mobility Limitation (2) Mood Disorders (2) Motor Neuron Disease (2) Multiple Myeloma (2) Multiple Sclerosis, Relapsing-Remitting (2) Muscular Dystrophies (2) Mutism (2) Mycoses (2) Myelodysplastic Syndromes (2) Myeloproliferative Disorders (2) Myositis (2) Necrosis (2) Neoplasms, Plasma Cell (2) Nerve Degeneration (2) Neurodevelopmental Disorders (2) Nidovirales Infections (2) Noncommunicable Diseases (2) Nutrition Disorders (2) Obesity, Morbid (2) Obsessive-Compulsive Disorder (2) Oral Manifestations (2) Pain, Postoperative (2) Peripheral Vascular Diseases (2) Phobia, Social (2) Phobic Disorders (2) Pneumonia, Pneumocystis (2) Psoriasis (2) Purpura, Thrombocytopenic, Idiopathic (2) Rare Diseases (2) Recurrence (2) Respiratory Sounds (2) Sarcoidosis (2) Shock, Septic (2) Small Cell Lung Carcinoma (2) Spinal Diseases (2) Sprains and Strains (2) Suicidal Ideation (2) Suicide (2) Tachycardia (2) Thoracic Diseases (2) Thrombocytopenia (2) Toxemia (2) Trauma and Stressor Related Disorders (2) Tuberculosis (2) Urinary Bladder, Overactive (2) Urinary Tract Infections (2) Uterine Cervical Neoplasms (2) Uveitis (2) Vision Disorders (2) Vision, Low (2) Yellow Fever (2) Abruptio Placentae (1) Acalculous Cholecystitis (1) Adenocarcinoma (1) Adjustment Disorders (1) Adrenal Insufficiency (1) Alcohol Drinking in College (1) Alcohol-Related Disorders (1) Alcoholic Intoxication (1) Alveolitis, Extrinsic Allergic (1) Amblyopia (1) Anemia, Aplastic (1) Angina, Stable (1) Anorexia (1) Anorexia Nervosa (1) Aortic Valve Stenosis (1) Apnea (1) Arthritis, Juvenile (1) Aspergillosis (1) Aspergillosis, Allergic Bronchopulmonary (1) Asphyxia Neonatorum (1) Asthenopia (1) Atrioventricular Block (1) Atrophy (1) Autonomic Nervous System Diseases (1) Back Pain (1) Bacteremia (1) Barotrauma (1) Birth Weight (1) Blister (1) Body Weight Changes (1) Bone Diseases, Metabolic (1) Bradycardia (1) Brain Concussion (1) Breast Cancer Lymphedema (1) Bronchial Diseases (1) Bronchiolitis (1) Bronchitis (1) Bronchitis, Chronic (1) Bronchopulmonary Dysplasia (1) Brucellosis (1) Bulimia (1) Calculi (1) Carcinoma, Hepatocellular (1) Carcinoma, Ovarian Epithelial (1) Carcinoma, Small Cell (1) Carcinoma, Squamous Cell (1) Cardiovascular Abnormalities (1) Cataract (1) Celiac Disease (1) Cellulitis (1) Cerebral Hemorrhage (1) Cerebral Palsy (1) Cerebrovascular Disorders (1) Chest Pain (1) Chlamydia Infections (1) Cholangiocarcinoma (1) Cholangitis (1) Cholecystitis (1) Cholecystitis, Acute (1) Chronic Traumatic Encephalopathy (1) Clostridium Infections (1) (1) Colonic Diseases (1) Communication Disorders (1) Compulsive Behavior (1) Consciousness Disorders (1) Constipation (1) Constriction, Pathologic (1) Conversion Disorder (1) (1) (1) Coronary Artery (1) Coronary Stenosis (1) (1) Cough (1) Coxsackievirus Infections (1) Cryopyrin-Associated Periodic Syndromes (1) Deafness (1) Death, Sudden, Cardiac (1) Dental Calculus (1) Dental Plaque (1) Depressi (1) Depressive Disorder, Treatment-Resistant (1) DiGeorge Syndrome (1) Diabetic Nephropathies (1) Diabetic Neuropathies (1) Diphtheria (1) (1) Down Syndrome (1) Dyspareunia (1) Emergence Delirium (1) Encephalitis (1) Endocarditis (1) Endophthalmitis (1) Endotoxemia (1) Enuresis (1) Epilepsy (1) Esophageal and Gastric Varices (1) Esophagitis, Peptic (1) Eye Diseases (1) Eye Infections (1) Fabry Disease (1) Facial Pain (1) Familial Mediterranean Fever (1) Fatty Liver (1) (1) Femoral Neck Fractures (1) Fetal Growth Retardation (1) Fetal Membranes, Premature Rupture (1) Fever of Unknown Origin (1) Fistula (1) Food Hypersensitivity (1) Fractures, Closed (1) Fractures, Stress (1) Gait Disorders, Neurologic (1) Genetic Diseases, Inborn (1) Genetic Predisposition to Disease (1) Gestational Weight Gain (1) Gingivitis, Necrotizing Ulcerative (1) Gout (1) (1) Headache Disorders, Secondary (1) Hearing Loss (1) Hearing Loss, Conductive (1) Heart Failure, Diastolic (1) Heart Murmurs (1) Helminthiasis (1) Hematoma (1) Hematoma, Subdural (1) Hematoma, Subdural, Chronic (1) Hemoglobinopathies (1) Hepatitis (1) Hepatitis A (1) Hepatitis C (1) Hepatitis, Alcoholic (1) Hereditary Autoinflammatory Diseases (1) Herpes Labialis (1) Herpes Zoster (1) Hodgkin Disease (1) Hyaline Membrane Disease (1) Hyperaldosteronism (1) Hypercapnia (1) Hyperphosphatemia (1) Hyperplasia (1) Hypersensitivity, Immediate (1) Hypertension, Pregnancy-Induced (1) Hypokalemia (1) Hyponatremia (1) Hypoparathyroidism (1) Hypotension (1) Iatrogenic Disease (1) Infant, Newborn, Diseases (1) Infec (1) Infecti (1) Infertility, Female (1) Infertility, Male (1) Intellectual Disability (1) Intestinal Atresia (1) Intracranial Hypertension (1) Intracranial Thrombosis (1) Jaundice, Obstructive (1) Joint Diseases (1) Keratoconjunctivitis (1) Keratosis (1) Keratosis, Actinic (1) Leishmaniasis (1) Leukemia, Lymphocytic, Chronic, B-Cell (1) Leukemia, Myeloid (1) Leukemia, Myelomonocytic, Acute (1) Leukemia, Myelomonocytic, Chronic (1) Liver Cirrhosis, Biliary (1) Liver Failure (1) Low Back Pain (1) Lung (1) Lyme Disease (1) Lymphedema (1) Lymphocytosis (1) Lymphoma, B-Cell (1) Lymphoma, Mantle-Cell (1) Macrophage Activation Syndrome (1) Malaria (1) Maternal Death (1) Maxillofacial Injuries (1) Memory Disorders (1) Meningitis (1) Meningitis, Meningococcal (1) Menorrhagia (1) Menstruation Disturbances (1) Microvascular Rarefaction (1) Mitochondrial Diseases (1) Molluscum Contagiosum (1) Monoclonal Gammopathy of Undetermined Significance (1) Mouth Diseases (1) Mouth, Edentulous (1) Movement Disorders (1) Mucositis (1) Multiple Chronic Conditions (1) Muscle Spasticity (1) Muscular Atrophy (1) Muscular Dystrophy, Duchenne (1) Myalgia (1) Myocardial Reperfusion Injury (1) Myofascial Pain Syndromes (1) Needlestick Injuries (1) Neonatal Sepsis (1) Neoplastic Cells, Circulating (1) Nephritis (1) Neurobehavioral Manifestations (1) Neurocognitive Disorders (1) Neuromyelitis Optica (1) Non-alcoholic Fatty Liver Disease (1) Obsessive Behavior (1) Olfactory Nerve Injuries (1) Orbital Cellulitis (1) Osteoarthritis, Hip (1) Osteochondritis (1) Osteomyelitis (1) Otitis Media with Effusion (1) Overweig (1) Pain (1) Pain, Procedural (1) Pancreatitis (1) Paraproteinemias (1) Paresis (1) Peanut Hypersensitivity (1) Perinatal Death (1) Periodontal Diseases (1) Peripheral Nervous System Diseases (1) Peritoneal Neoplasms (1) Pharyngeal Diseases (1) Pleuropneumonia (1) (1) (1) Pneumonia, Bacterial (1) Pneumonia, V (1) Pre-Eclampsia (1) Pregnancy in Diabetics (1) Preleukemia (1) Primary Dysautonomias (1) Prostatic Hyperplasia (1) Protein-Energy Malnutrition (1) Psychophysiologic Disorders (1) Puerperal Infection (1) Pulmonary Alveolar Proteinosis (1) Pulmonary Aspergillosis (1) Pulmonary Atelectasis (1) Pulmonary Eosinophilia (1) Radiculopathy (1) Rectal Neoplasms (1) Reperfusion Injury (1) (1) (1) Respiratory Distress Sy (1) Respiratory Hypersensitivity (1) Retinal Vein Occlusion (1) Rupture (1) Sarcoidosis, Pulmonary (1) Sarcopenia (1) Schizophrenia Spectrum and Other Psychotic Disorders (1) (1) Scleroderma, Localized (1) Scleroderma, Systemic (1) Self-Injurious Behavior (1) Severe Acute Respiratory Syn (1) Sexually Transmitted Diseases (1) Sexually Transmitted Diseases, Bacterial (1) Shock, Cardiogenic (1) Short Bowel Syndrome (1) Signs and Symptoms, Digestive (1) Skin Abnormalities (1) Skin Diseases (1) Skin Manifestations (1) Skin Neoplasms (1) Skull Fractures (1) Sleep Apnea, Central (1) Soft Tissue Neoplasms (1) Somatoform Disorders (1) Spinal Stenosis (1) Spondylarthritis (1) Spondylolisthesis (1) Status Epilepticus (1) Stillbirth (1) Stomatitis (1) Str (1) Stress Disorders, Traumatic, Acute (1) Subarachnoid Hemorrhage (1) Superinfection (1) Syncope (1) Syncope, Vasovagal (1) Tachycardia, Sinus (1) Tachycardia, Ventricular (1) Temporomandibular Joint Disorders (1) Temporomandibular Joint Dy (1) Temporomandibular Joint Dysfunction Syndrome (1) Thalassemia (1) Thrombophlebitis (1) Torsades de Pointes (1) Tourette Syndrome (1) Trauma, Nervous System (1) Trichuriasis (1) Tuberculosis, Pulmonary (1) Ulce (1) Urinary Bladder, Underactive (1) Urinary Incontinence (1) Urinary Retention (1) Urologic Diseases (1) Urticaria (1) Uterine Neoplasms (1) Vaginal Neoplasms (1) Ventricular Dysfunction, Right (1) Virus Dis (1) Von Willebrand Diseases (1) Vulvar Neoplasms (1) Weight Gain (1) Xerostomia (1) beta-Thalassemia (1)

D008173: Lung Diseases, Obstructive

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (25)


Name (Synonyms) Correlation
drug3433 Tezepelumab Wiki 0.39
drug1206 Ensifentrine Wiki 0.39
drug1600 ION-827359 Wiki 0.28
Name (Synonyms) Correlation
drug3103 Serology for Covid-19 Wiki 0.28
drug3183 Sputum and blood sampling Wiki 0.28
drug619 COVID 19 Diagnostic Test Wiki 0.28
drug1587 ID NOW vs. Accula Wiki 0.28
drug1095 Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki 0.28
drug2966 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.28
drug1601 IP-10 in CDS protocol Wiki 0.28
drug94 ARALAST NP Wiki 0.28
drug891 Control swab Wiki 0.28
drug1236 Exercise Training Only Wiki 0.28
drug1237 Exercise and Cognitive Training Wiki 0.28
drug2685 Prototype swab Wiki 0.28
drug1742 Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki 0.28
drug401 BI 764198 Wiki 0.20
drug38 2D Telemedicine Wiki 0.20
drug46 3D Telemedicine Wiki 0.16
drug1978 Matching placebo Wiki 0.16
drug390 BCG vaccine Wiki 0.16
drug464 Best Practice Wiki 0.12
drug3257 Standard treatment Wiki 0.11
drug2505 Placebo Wiki 0.09
drug3485 Tocilizumab Wiki 0.05

Correlated MeSH Terms (37)


Name (Synonyms) Correlation
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.80
D008171 Lung Diseases, NIH 0.42
D029481 Bronchitis, Chronic NIH 0.28
Name (Synonyms) Correlation
D001991 Bronchitis NIH 0.28
D001982 Bronchial Diseases NIH 0.28
D006969 Hypersensitivity, Immediate NIH 0.28
D012130 Respiratory Hypersensitivity NIH 0.28
D008168 Pulmonary NIH 0.28
D018410 Pneumonia, Bacterial NIH 0.28
D004646 Emphysema NIH 0.20
D000208 Acute Disease NIH 0.20
D019896 Alpha 1-Antitrypsin Deficiency NIH 0.20
D003139 Common Cold NIH 0.16
D005356 Fibromyalgia NIH 0.14
D001249 Asthma NIH 0.14
D010003 Osteoarthritis, NIH 0.12
D006967 Hypersensitivity, NIH 0.12
D012140 Respiratory Tract Diseases NIH 0.12
D007154 Immune System Diseases NIH 0.11
D007676 Kidney Failure, Chronic NIH 0.10
D003327 Coronary Disease NIH 0.10
D003324 Coronary Artery Disease NIH 0.10
D006331 Heart Diseases NIH 0.08
D012120 Respiration Disorders NIH 0.07
D020521 Stroke NIH 0.07
D011024 Pneumonia, Viral NIH 0.06
D006973 Hypertension NIH 0.06
D002318 Cardiovascular Diseases NIH 0.05
D007249 Inflammation NIH 0.05
D009369 Neoplasms, NIH 0.05
D012141 Respiratory Tract Infections NIH 0.05
D007239 Infection NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03
D011014 Pneumonia NIH 0.03
D014777 Virus Diseases NIH 0.03
D003141 Communicable Diseases NIH 0.02

Correlated HPO Terms (13)


Name (Synonyms) Correlation
HP:0006536 Pulmonary obstruction HPO 0.88
HP:0006510 Chronic pulmonary obstruction HPO 0.65
HP:0002088 Abnormal lung morphology HPO 0.38
Name (Synonyms) Correlation
HP:0012387 Bronchitis HPO 0.28
HP:0004469 Chronic bronchitis HPO 0.28
HP:0002099 Asthma HPO 0.14
HP:0012393 Allergy HPO 0.12
HP:0001677 Coronary artery atherosclerosis HPO 0.11
HP:0001297 Stroke HPO 0.08
HP:0011947 Respiratory tract infection HPO 0.05
HP:0002664 Neoplasm HPO 0.05
HP:0001626 Abnormality of the cardiovascular system HPO 0.05
HP:0002090 Pneumonia HPO 0.03

Clinical Trials

Navigate: Correlations   HPO

There are 13 clinical trials


1 Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific

Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.

NCT03151395
Conditions
  1. Respiratory Disorders
Interventions
  1. Other: Sputum and blood sampling
MeSH:Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases
HPO:Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.

Measure: Occurrence of potential bacterial in sputum of stable COPD patients.

Time: Over the course of 1 year

Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.

Measure: Occurrence of potential bacterial in sputum during AECOPD.

Time: Over the course of 1 year

Description: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.

Measure: Occurrence of viral pathogens in sputum of stable COPD patients.

Time: Over the course of 1 year

Description: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.

Measure: Occurrence of viral pathogens in sputum during AECOPD.

Time: Over the course of 1 year

Secondary Outcomes

Description: Including (but not necessarily limited to) H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus and P. aeruginosa. The proportion of sputum samples obtained at each confirmed stable/AECOPD visit and positive for specific bacterial pathogens by PCR will be computed with 95% confidence intervals.

Measure: Occurrence of potential bacterial pathogens in sputum of stable COPD patients and during AECOPD, as measured by real-time qualitative PCR/ quantitative PCR and compared to data from bacteriological methods.

Time: Over the course of 1 year

Description: The proportion of sputum samples obtained at each AECOPD visit and positive for specific bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial/viral species) will be computed with 95% confidence intervals by any severity (mild, moderate and severe).

Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum during AECOPD by severity of AECOPD.

Time: Over the course of 1 year

Description: The proportion of sputum samples obtained at each confirmed stable visit and positive for bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial / viral species) will be computed with 95% confidence intervals by Gold grade at enrolment.

Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum of stable COPD patients by GOLD grade.

Time: Over the course of 1 year

Description: The following incidence rates will be computed, with 95% confidence intervals (CI): All-cause AECOPD. AECOPD having sputum containing bacterial pathogens found by PCR or by bacteriological methods or by both methods (overall and by, but not limited to, the following bacterial species: H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus, and P. aeruginosa). The 95% CI of the incidence rate will be computed using a model which accounts for repeated events. The incidence rates described above will also be computed for mild, moderate severe AECOPD and by GOLD grade at enrolment.

Measure: Incident rate (per subject per year) of any AECOPD overall and by GOLD grade.

Time: Over the course of 1 year

Description: Classification of severity according to the intensity of medical intervention required: mild: controlled with an increase in dosage of regular medications; moderate: requires treatment with systemic corticosteroids and/ or antibiotics; severe: requires hospitalisation.

Measure: Number of mild, moderate or severe AECOPD overall and by GOLD grade.

Time: Over the course of 1 year

Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the number of days of AECOPD episodes will be presented.

Measure: Number of days of AECOPD episodes overall and by AECOPD severity.

Time: Over the course of 1 year

Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the CAT scores will be tabulated at each respective visit.

Measure: COPD assessment test (CAT) score in stable COPD patients and during AECOPD.

Time: Over the course of 1 year

Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the SGRQ-C scores will be tabulated at each respective visit.

Measure: St. George's Respiratory Questionnaire (SGRQ-C) score in stable COPD patients.

Time: Over the course of 1 year

Description: The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator FEV1. Summary statistics (mean, median, standard deviation, maximum and minimum) on post bronchodilator FEV1% of predicted normal value will be tabulated at each respective visit.

Measure: Forced expiratory volume in 1 second (FEV1%) of predicted normal value in stable COPD patients.

Time: At Pre-Month 0 and Month 12

Description: Healthcare use for each COPD patient will be obtained through review of the subject's medical record (aided by subject self-reporting). Healthcare utilisation includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations.

Measure: Assessment of the Healthcare utilization.

Time: Over the course of 1 year
2 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)

A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.

NCT03688074
Conditions
  1. Asthma
  2. Bronchial Diseases
  3. Respiratory Tract Diseases
  4. Lung Diseases, Obstructive
  5. Lung Diseases
  6. Respiratory Hypersensitivity
  7. Hypersensitivity, Immediate
  8. Hypersensitivity
  9. Immune System Diseases
Interventions
  1. Biological: Tezepelumab
  2. Other: Placebo
MeSH:Asthma Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Immune System Diseases Hypersensitivity, Immediate Inflammation
HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction

Primary Outcomes

Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

Secondary Outcomes

Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
3 A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT04039113
Conditions
  1. Chronic Obstructive Pulmonary Disease (COPD)
Interventions
  1. Biological: Tezepelumab
  2. Other: Placebo
MeSH:Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive
HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.

Measure: Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo)

Time: Over 52 Weeks

Secondary Outcomes

Description: Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio

Measure: Time to first moderate or severe COPD exacerbation

Time: By Week 52

Description: Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio

Measure: Proportion with at least one moderate/severe COPD exacerbation

Time: Over 52 Weeks

Description: The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.

Measure: Severe COPD exacerbation rate ratio (tezepelumab vs. placebo)

Time: Over 52 Weeks

Description: Difference in change from baseline in pre-BD forced expiratory volume in 1 second (FEV1) in tezepelumab arm as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.

Measure: Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

Time: Baseline, Week 52

Description: Proportion of subjects achieving a decrease of 4 units or more in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 52, i.e. minimum clinically important difference (MCID). Outcome measure: odds ratio

Measure: Change in respiratory health status/health-related quality of life

Time: Baseline, Week 52

Description: Difference (tezepelumab vs. placebo) in SGRQ from baseline at Week 52. SGRQ is a 50-item patient reported outcome questionnaire. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0% indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. Decrease of 4 units is associated with a minimum clinically important difference (MCID).

Measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score

Time: Baseline, Week 52

Description: Difference (tezepelumab vs. placebo) in COPD assessment tool (CAT) from baseline at Week 52. CAT is an 8-item patient reported outcome questionnaire developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. The score ranges from 0 to 40, with higher scores indicating greater COPD impact on health status.

Measure: Change from baseline in the COPD Assessment Test (CAT) Total Score

Time: Baseline, Week 52

Description: Serum trough concentration of tezepelumab

Measure: Evaluate pharmacokinetics of tezepelumab

Time: Weeks 0, 4, 12, 24, 36, 52, 64

Description: Incidence of anti-drug antibodies (ADA)

Measure: Evaluate immunogenicity of tezepelumab

Time: Over 52 weeks
4 Time of Recovery and Prognostic Factors of COVID-19 Pneumonia

It has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities. In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients. Amazingly, in the two major studies published in the Lancet (Zhou F et al Lancet 2020) and in the New England Journal of Medicine (Guan W et al 2020), the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection. The primary end-point of our prospective, observational study is to assess the recovery rate in patients with diagnosis of Covid-19 pneumonia. Among the other secondary end-points, we intend to find the predictors of the time to clinical improvement or hospital discharge in patients affected by Covid-19 pneumonia.

NCT04324684
Conditions
  1. Pneumonia, Viral
  2. Hypertension
  3. Diabetes Mellitus
  4. Obesity
  5. Cardiovascular Diseases
  6. Obstructive Lung Disease
MeSH:Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive Cardiovascular Diseases
HPO:Abnormal lung morphology Abnormality of the cardiovascular system Pneumonia Pulmonary obstruction

Primary Outcomes

Description: mean rate of recovery in patients with diagnosis of Covid-19 pneumonia, who present with complications at the time of hospital admission (such as diabetes, obesity, cardiovascular disease, hypertension or respiratory failure), with the mean recovery rate in patients without any of the above-mentioned complications.

Measure: rate of recovery

Time: 3 weeks

Secondary Outcomes

Description: comparison of the survival curves (times to improvement) in the two groups (patients with and without complications) and among patients presenting with different types of complications

Measure: time to improvement

Time: 3 weeks

Description: the efficacy of different pharmaceutical treatment against Covid-19

Measure: efficacy of treatments

Time: 3 weeks

Description: liver, kidney or multiorgan failure, cardiac failure

Measure: organ failure

Time: 3 weeks
5 Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

NCT04326309
Conditions
  1. COVID-19
  2. Coronavirus Infections
  3. Hay Fever
  4. Asthma
  5. Chronic Obstructive Pulmonary Disease
  6. Influenza
  7. Common Cold
  8. Respiratory Tract Infections
  9. Healthy
MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Common Cold Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Chronic pulmonary obstruction Pulmonary obstruction Respiratory tract infection

Primary Outcomes

Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

Measure: Dataset size

Time: 14 days

Secondary Outcomes

Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

Measure: Cough sound identification

Time: 14 days

Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

Measure: Improvement of the existing model

Time: 14 days

Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

Measure: Evaluate the usability of the application

Time: 14 days
6 Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

NCT04361552
Conditions
  1. Cerebrovascular Accident
  2. Chronic Obstructive Pulmonary Disease
  3. Chronic Renal Failure
  4. Coronary Artery Disease
  5. Diabetes Mellitus
  6. Malignant Neoplasm
  7. SARS Coronavirus 2 Infection
Interventions
  1. Other: Best Practice
  2. Biological: Tocilizumab
MeSH:Infection Neoplasms Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease
HPO:Chronic pulmonary obstruction Coronary artery atherosclerosis Neoplasm Pulmonary obstruction Stroke

Primary Outcomes

Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.

Measure: 7-day length of invasive mechanical ventilation (MV)

Time: Up to 7 days

Description: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: 30-day mortality rate

Time: Up to 30-day after randomization

Secondary Outcomes

Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of intensive care (ICU) transfer

Time: Up to 2 years

Description: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of invasive mechanical ventilation

Time: Up to 2 years

Description: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

Measure: Rate of tracheostomy

Time: Up to 2 years

Description: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test

Measure: Length of ICU stay

Time: Up to 2 years

Measure: Length of hospital stay

Time: Up 2 years
7 Major Determinants of COVID-19 Associated Pneumonia

Molecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases. Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal. Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies. In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.

NCT04387799
Conditions
  1. Pneumonia, Viral
  2. Pneumonia, Bacterial
  3. Coronavirus Infection
  4. Obstructive Lung Disease
Interventions
  1. Diagnostic Test: Serology for Covid-19
MeSH:Pneumonia, Bacterial Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive
HPO:Abnormal lung morphology Pneumonia Pulmonary obstruction

Primary Outcomes

Description: assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.

Measure: Serology

Time: 3 weeks

Secondary Outcomes

Description: to find if the combination of CT scan and serology could help us in the identification of those patients who were initially negative at laboratory testing alone.

Measure: Efficacy of CT scan and Serology

Time: 3 weeks

Description: the efficacy of different pharmaceutical treatments against Covid-19

Measure: Efficacy of different pharmaceutical treatments

Time: 3 weeks
8 A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial

Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

NCT04414267
Conditions
  1. COVID-19
  2. Virus Diseases
  3. Corona Virus Infection
  4. Coronary Heart Disease
  5. Chronic Obstructive Pulmonary Disease
Interventions
  1. Biological: BCG vaccine
  2. Biological: Placebo
MeSH:Infection Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Heart Diseases Coronary Disease
HPO:Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

Time: Visit 3 (90 +/- 5 days)

Secondary Outcomes

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

Time: Visit 4 (135 +/- 5 days)

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

Time: Visit 5 (180 +/- 5 days)

Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

Measure: Prevalence of IgG/IgM against SARS-CoV-2

Time: Screening Visit and Visit 3 (90 +/- 5 days)

Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

Measure: The impact of new cardiovascular events between the two study groups

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)
9 A Prospective, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of ARALAST NP 60 mg/kg and 120 mg/kg for Alpha-1 Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E)

The purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous lung tissue measured by lung density change in participants with A1PI deficiency and COPD-E.

NCT04440488
Conditions
  1. Chronic Obstructive Pulmonary Disease
  2. Alpha1-antitrypsin Deficiency
Interventions
  1. Biological: ARALAST NP
MeSH:Alpha 1-Antitrypsin Deficiency Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Emphysema
HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: Annual rate of the physiologically adjusted lung density change will be measured as the 15th percentile of the lung density measurements (PD15) as assessed by Computed Tomography (CT) densitometry at total lung capacity (TLC). CT lung density at the 15th percentile (PD15) is the threshold below which 15 percentage (%) of the voxels have lower densities and is used as the parameter for estimating the rate of lung density decline. Annual rate of the physiologically adjusted lung density change will be tested in a fixed comparision sequence 1. ARALAST NP 120 mg/kg BW/week group versus (vs) external placebo group, 2. ARALAST NP120 mg/kg BW/week vs 60 mg/kg BW/week, 3. ARALAST NP 60 mg/kg BW/week group vs external placebo group.

Measure: Annual Rate of the Physiologically Adjusted Lung Density Change

Time: Baseline, up to Week 104

Secondary Outcomes

Description: COPD exacerbations are defined as an acute worsening of respiratory symptoms that results in additional therapy and will be assessed according to the classification in GOLD criteria (2020) as follows: Moderate (treated with short acting bronchodilators [SABDs] plus antibiotics and/or oral corticosteroids) and Severe (required hospitalizations or a visit to the emergency room).

Measure: Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Time: Baseline, up to Week 104

Description: Annual rate of change in post-bronchodilator FEV1 will be assessed.

Measure: Annual Rate of Change in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Time: Baseline, up to Week 104

Description: An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this IP or medicinal product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. TEAE's will include related, serious adverse events (SAEs), suspected adverse reactions plus adverse reactions of interest, temporally-associated adverse events (AEs) with onset during infusion or within 24 hours following the end of IP infusion, and AEs resulting in changes to infusion dose.

Measure: Number of Participants with Treatment-Emergent Adverse Events (TEAE's)

Time: From Start of the study drug administration up to End of the study (up to Week 105)

Description: Number of participants who develop anti- A1PI antibodies following treatment with ARALAST NP will be assessed.

Measure: Number of Participants Who Develop Anti-A1PI Antibodies Following Treatment With ARALAST NP

Time: From Start of the study drug administration up to End of the study (up to Week 105)

Description: Plasma trough level of antigenic and functional A1PI for ARALAST NP at each dose level (ARALAST NP 60 mg/kg BW/week, ARALAST NP 120 mg/kg BW/week) will be assessed.

Measure: Plasma Trough Level of Antigenic and Functional A1PI for ARALAST NP at each dose Level

Time: Pre-dose, Weeks 4, 13, 28, 52, 78, 91, 104, 105
10 A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis

The purpose of this study is to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in patients with mild to moderate COPD with CB.

NCT04441788
Conditions
  1. Chronic Bronchitis
  2. Chronic Obstructive Pulmonary Disease
Interventions
  1. Drug: ION-827359
  2. Drug: Placebo
MeSH:Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Bronchitis, Chronic Acute Disease
HPO:Abnormal lung morphology Bronchitis Chronic bronchitis Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Measure: Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo

Time: From Baseline up to average of Weeks 13 and 14

Secondary Outcomes

Description: The EXACT (E-RS) scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with COPD. The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness, cough and sputum, and chest symptoms. The E-RS will be collected on the daily e-diary, which will include all 14 items from the EXACT questionnaire.

Measure: Change From Baseline in the EXACT Respiratory Symptoms (E-RS) Daily Symptom Diary to the Primary Time Point

Time: One week prior to first dose through one week after the last dose.

Description: The CAT is an eight-item questionnaire that will be completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. The CAT provides a score of 0-40 to indicate the impact of the disease.

Measure: Change From Baseline in the COPD Assessment Test (CAT) to the Week 14 Time Point

Time: From Baseline up to Week 14

Description: The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. Scores of the SGRQ-C range from 0 to 100, with higher scores indicating more limitations.

Measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) to the Week 14 Time Point

Time: From Baseline up to Week 14

Measure: Change from Baseline in Post-Bronchodilator FEV1

Time: From Baseline up to average of Weeks 13 and 14

Measure: Cmax: Maximum Observed Plasma Concentration for ION-827359

Time: Up to Week 24

Measure: Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359

Time: Up to Week 24

Measure: AUC[0-t]: Area Under the Plasma Concentration-Time Curve from Time Zero to t for ION-827359

Time: Up to Week 24

Measure: Incidence of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), Graded by Severity

Time: Up to Week 24

Measure: Number of Participants With Abnormal Laboratory Values

Time: Up to Week 24

Measure: Number of Participants With Abnormal Vital Signs Measurements

Time: Up to Week 24
11 Combined Cognitive and Exercise Training for Older Adults: Feasibility & Effectiveness

The overarching aim of this project is to implement and evaluate a proven cognitive training regimen in combination with a community exercise program among older adults who attend wellness exercise programs at the YMCA. To support this aim, the investigators have developed a collaboration with the YMCA of Kitchener-Waterloo, which offer exercise programs targeted to older adults. The specific objectives are: (1) to evaluate the feasibility of a combined exercise and cognitive training in a community-setting among older adults; and (2) to conduct a preliminary evaluation and comparison of changes in cognitive function, physical function, well-being and self-efficacy with 12-weeks of combined exercise and cognitive training versus exercise alone. The hypothesis for each objective are as follows: (1) It is anticipated that this program will be feasible to implement and will be well accepted by the participants and exercise providers. (2) The investigators may not have the power to find statistically significant differences between the control and experimental groups for physical and cognitive function. However, the investigators expect to observe positive changes between the pre- and post-assessments, suggesting improved cognitive function and mobility as a result of the 12-week program.

NCT04515758
Conditions
  1. Osteo Arthritis
  2. Osteoporosis
  3. Joint Replacement
  4. Fibromyalgia
  5. High Blood Pressure
  6. Stable Heart Conditions
  7. Chronic Obstructive Pulmonary Disease
  8. Diabetes
  9. Obesity
Interventions
  1. Other: Exercise and Cognitive Training
  2. Other: Exercise Training Only
MeSH:Osteoporosis Fibromyalgia Osteoarthritis Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Hypertension
HPO:Chronic pulmonary obstruction Hypertension Osteoarthritis Pulmonary obstruction

Primary Outcomes

Description: Total number of people enrolled divided by the total number of people invited to participate (multiplied by 100 to calculate a percentage)

Measure: Recruitment Rate

Time: Pre-program (baseline)

Description: Percentage of people who completed the full program and all assessments

Measure: Completion Rate

Time: Through study completion, 12 weeks

Description: Percentage of people who attended program sessions (exercise and cognitive training components)

Measure: Attendance

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Participant and instructors rating of program components and overall program (via hand-written questionnaire). Participants and instructors must rate their level of agreement (1 = strongly disagree, 2 = disagree, 3 = no opinion, 4 = agree, 5 = strongly agree) with various statements. The higher the rating, the greater the satisfaction. They also must rate if the difficulty of the program was optimal, somewhat easy or hard, or too easy or hard. They must also specify how much money they would be willing to spend on the program. They are also given an opportunity to record optional additional comments/recommendation.

Measure: Change in Participant and Instructor Rating of experience, satisfaction, and feasibility of program

Time: Mid-point (6 weeks) and post-program (12 weeks)

Description: Financial cost of running program (equipment purchased for study - cognitive training tablet and stands - and YMCA staff pay) as reported by researcher and YMCA staff

Measure: Cost of program

Time: Post-program (12 weeks)

Description: Self-reported biological sex (at birth) using basic demographics questionnaire

Measure: Sex

Time: Pre-program (baseline)

Description: One-on-one interview with researcher, answering broad questions about their experience in the program and study

Measure: Participant and Instructor perceived program experience and satisfaction

Time: Post-program (at 12 weeks)

Description: Experience of participants and instructors will also be observed by the researcher (observational notes will be taken by the researcher during each class). No names of participants and instructors will be recorded.

Measure: Participant and Instructor observer-perceived program experience and satisfaction

Time: Throughout entire intervention (12 weeks, 2 sessions/week per group)

Description: Self-reported years of formal education and training (training years for instructors only) using basic demographics questionnaire

Measure: Education

Time: Pre-program (baseline)

Description: Self-reported previous and current occupations using basic demographics questionnaire

Measure: Occupation

Time: Pre-program (baseline)

Description: Self-reported previous and current medical conditions using basic demographics questionnaire

Measure: Medical Condition

Time: Pre-program (baseline)

Description: Self-reported previous and current medications using basic demographics questionnaire

Measure: Medications

Time: Pre-program (baseline)

Description: Using the Montreal Cognitive Assessments (brief clinical tool) to assess visual/spatial abilities, working memory, executive functioning, language, abstraction, and orientation). Will be used to describe participants' baseline cognitive status (a score out of 30 is measured).

Measure: Montreal Cognitive Assessment (global cognitive function)

Time: Pre-program (baseline)

Description: Using the International Physical Activities Questionnaire (IPAQ) to assess physical activity level based on self-reported frequency and duration of job-related, house work-related, transportation-related, and leisure-related physical activities done in the past week. METS-minutes/week will be calculated and reported (i.e. take the number of minutes doing an activity in the past week and multiply by the appropriate metabolic equivalent, which will vary based on the intensity of the physical activity).

Measure: Physical Activity Level

Time: Pre-program (baseline)

Description: Using a cognitive activity scale (score of 0-4 per activity) that requires participants to self-report how often they typically engage in a variety of mentally stimulating activities (i.e. playing card games, reading, cooking, etc.) The more frequently they engage in the activity, the higher the score.

Measure: Participant cognitive activity

Time: Pre-program (baseline)

Description: Using a scale (score of 0-3 per group) that requires participants to self-report how often they typically interact (face-to-face or virtually) with different groups of people (i.e. their spouse, family, friends, co-workers, etc.). The more frequently they interact with the group, the higher the score.

Measure: Participant social activity

Time: Pre-program (baseline)

Description: Self-reported years of age using basic demographics questionnaire

Measure: Participant and Instructor Age

Time: Pre-program (baseline)

Secondary Outcomes

Description: STROOP task which assesses the length of time (seconds) it takes for a participant to correctly name a coloured square (test 1), read the name of a colour (test 2), and say the name of the colour that a word is printed in (test 3). Number of corrected and uncorrected errors are also recorded.

Measure: Change in Stroop Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Trails Making Test Part A and B. Part A assesses visual search (participants must connect numbered circles in ascending numerical order (1-2-3-etc). Part B assesses working memory and task-switching (participants must connect circles in ascending numerical and alphabetical order (1-A-2-B- etc.). Time to complete the tests (second) and errors (number) made during the tests are recorded.

Measure: Change in Trail Making Task Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) heart rate (beats per minute) using an automatic blood pressure cuff

Measure: Change in Resting Heart Rate

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Resting (seated) blood pressure (millimeters of mercury) using an automatic blood pressure cuff

Measure: Change in Resting Systolic and Diastolic Blood Pressure

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Using hand dynamometer (assessing grip strength in lbs) for right and left hand (two trials per hand)

Measure: Change in Grip Strength

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Weight (using automatic scale to measure in lbs, converted to kg) and height (measured in feet and inches, converted to meters) measured and combined to provide BMI (kg/m^2)

Measure: Change in Body Mass Index (BMI)

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Divide waist circumference (cm) by hip circumference (cm) to get ratio calculation

Measure: Change in Hip-to-Waist Circumference Ratio

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Timed Up-and-Go (participants stand up from a chair, walk 6 meters, turn around an object, walk back to chair, and sit down). Time to complete test is measured (seconds) and assessor's observational notes of performance are taken.

Measure: Change in Timed Up-and-Go Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Agility and functional balance will be assessed using the Four Square Step Test (participants must step over lines that are set up in a cross formation, creating 4 quadrants. They must step forward, backward, and side to side in a specific pattern (i.e. from quadrant 1 to quadrant 2, to quadrant 3, to quadrant 4). Time to complete test is recorded in seconds.

Measure: Change in Four Square Step Test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Lower body strength will be assessed using the 5 Time Sit-to-Stand (participants must complete 5 sit-to-stands from a chair as fast as they can). Time to complete all 5 is recorded in seconds.

Measure: Change in Sit-to-Stand Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Functional fitness will be assessed using the 6 minute walk (participants walk along indoor track for 6 minutes). The number of laps achieved in 6 minutes is recorded. Assessor's observational notes of walking performance is also recorded.

Measure: Change in 6-minute walk test Performance

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Well-being will be self-reported using the "Vitality-Plus Scale" (self-reported general health questionnaire - rating of sleep quality, appetite, general energy level, etc.). Participants rate their degree of health on a scale from 1 - 5 (the higher the rating, the better their perceived overall well-being).

Measure: Change in Overall Well-being

Time: Pre-program (baseline) and post-program (12 weeks)

Description: Bandura Scale (named after the researcher who developed it) - self-reported rating of confidence (0 - 100%) to continue exercising routinely in various hypothetical situations (i.e. if one is sick, if the weather is poor, etc). The greater the confidence, the higher the score

Measure: Change in Exercise-related Self-Efficacy

Time: Pre-program (baseline) and post-program (12 weeks)
12 A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD

The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

NCT04535986
Conditions
  1. Chronic Obstructive Pulmonary Disease
Interventions
  1. Drug: Ensifentrine
  2. Drug: Placebo
MeSH:Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: Change from baseline of Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h

Measure: Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h

Time: 12 weeks

Secondary Outcomes

Description: Change from baseline of Average FEV1 AUC0-4h post-dose at Week 12

Measure: Average FEV1 AUC0-4h post-dose at Week 12

Time: 12 weeks

Description: Change from baseline in Peak FEV1 over 4 hours post dose at Week 12

Measure: Peak FEV1 over 4 hours post dose at Week 12

Time: 12 weeks

Description: Change from baseline as a weekly average of Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24

Measure: Weekly average of Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24

Time: 24 weeks

Description: Change from baseline of SGRQ total score at Week 24

Measure: St. George's Respiratory Questionnaire (SGRQ) total score at Week 24

Time: 24 weeks

Description: Change from baseline of Morning trough FEV1 at Week 12

Measure: Morning trough FEV1 at Week 12

Time: 12 weeks

Description: The proportion of St. George's Respiratory Questionnaire (SGRQ) responders at Week 24.

Measure: St. George's Respiratory Questionnaire (SGRQ)

Time: 24 weeks

Description: Change from baseline of Rescue medication use at Week 24

Measure: Rescue medication use at Week 24

Time: 24 weeks

Description: Transitional Dyspnea Index (TDI) at Week 24

Measure: Transitional Dyspnea Index (TDI) at Week 24

Time: 24 weeks

Description: Change from baseline Evening trough FEV1 at Week 12

Measure: Evening trough FEV1 at Week 12

Time: 12 weeks

Description: Change from baseline Peak FEV1

Measure: Peak FEV1 at Week 6 and Week 24

Time: 6 and 24 weeks

Description: Change from baseline morning trough FEV1

Measure: Morning trough FEV1 at Week 6 and Week 24

Time: 6 and 24 weeks

Description: Change from baseline evening trough FEV1

Measure: Evening trough FEV1 at Week 6 and Week 24

Time: 6 and 24 weeks

Description: Change from baseline FEV1 AUC0-4h

Measure: FEV1 AUC0-4h at Week 6 and Week 24

Time: 6 and 24 weeks

Description: Change from baseline E-RS Total Score

Measure: Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 6 and Week 12

Time: 6 and 12 weeks

Description: Change from baseline SGRQ responder analysis

Measure: St. George's Respiratory Questionnaire (SGRQ) responder analysis at Week 6 and Week 12

Time: 6 and 12 weeks

Description: Change from baseline TDI

Measure: TDI at Week 6 and Week 12

Time: 6 and 12 Weeks

Description: Change from baseline of SGRQ total score at Weeks 6 and 12

Measure: St. George's Respiratory Questionnaire (SGRQ) total score at Weeks 6 and 12

Time: 6 Weeks and 12 weeks

Description: Change from baseline of Rescue medication use at Weeks 6 and 12

Measure: Rescue medication use at Weeks 6 and 12

Time: 12 weeks
13 A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

NCT04542057
Conditions
  1. Chronic Obstructive Pulmonary Disease
Interventions
  1. Drug: Ensifentrine
  2. Drug: Placebo
MeSH:Lung Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: Change from baseline of Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h

Measure: Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h

Time: 12 weeks

Secondary Outcomes

Description: Change from baseline of Average FEV1 AUC0-4h post-dose at Week 12

Measure: Average FEV1 AUC0-4h post-dose at Week 12

Time: 12 weeks

Description: Change from baseline of Peak FEV1 over 4 hours post-dose at Week 12

Measure: Peak FEV1 over 4 hours post-dose at Week 12

Time: 12 weeks

Description: Change from baseline as a weekly average of Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24

Measure: Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24

Time: 24 weeks

Description: Change from baseline of SGRQ total score at Week 24

Measure: St. George's Respiratory Questionnaire (SGRQ) total score at Week 24

Time: 24 weeks

Description: Change from baseline of Morning trough FEV1 at Week 12

Measure: Morning trough FEV1 at Week 12

Time: 12 weeks

Description: The proportion of St. George's Respiratory Questionnaire (SGRQ) responders at Week 24.

Measure: St. George's Respiratory Questionnaire (SGRQ) responders at Week 24

Time: 24 weeks

Description: Change from baseline of Rescue medication use at Week 24

Measure: Rescue medication use at Week 24

Time: 24 weeks

Description: Transitional Dyspnea Index (TDI) at Week 24

Measure: Transitional Dyspnea Index (TDI) at Week 24

Time: 24 weeks

Description: Change from baseline Evening trough FEV1 at Week 12

Measure: Evening trough FEV1 at Week 12

Time: 12 weeks

Description: Change from baseline Peak FEV1

Measure: Peak FEV1 at Week 6 and Week 24

Time: 6 or 24 weeks

Description: Change from baseline morning trough FEV1

Measure: Morning trough FEV1 at Week 6 and Week 24

Time: 6 or 24 weeks

Description: Change from baseline evening trough FEV1

Measure: Evening trough FEV1 at Week 6 and Week 24

Time: 6 or 24 weeks

Description: Change from baseline FEV1 AUC0-4h

Measure: FEV1 AUC0-4h at Week 6 and Week 24

Time: 6 or 24 weeks

Description: Change from baseline E-RS Total Score

Measure: Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 6 and Week 12

Time: 6 or 12 weeks

Description: Change from baseline SGRQ responder analysis

Measure: SGRQ responder analysis at Week 6 and Week 12

Time: 6 or 12 weeks

Description: Change from baseline TDI

Measure: TDI at Week 6 and Week 12

Time: 6 or 12 weeks

Description: Change from baseline of SGRQ total score

Measure: St. George's Respiratory Questionnaire (SGRQ) total score at Weeks 6 and 12

Time: 6 or 12 weeks

Description: Change from baseline of Rescue medication use

Measure: Rescue medication use at Weeks 6 and 12

Time: 6 or 12 weeks

HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook