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Name (Synonyms) | Correlation | |
---|---|---|
drug752 | CFTR Modulators Wiki | 0.30 |
drug4362 | Tezacaftor/Ivacaftor + Ivacaftor Wiki | 0.21 |
drug695 | Brensocatib 10 mg Wiki | 0.21 |
Name (Synonyms) | Correlation | |
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drug1539 | Esomeprazole 20mg Wiki | 0.21 |
drug1223 | D-dimer,CBC.ESR,CRP, Wiki | 0.21 |
drug1054 | Collagen-Polyvinylpyrrolidone Wiki | 0.21 |
drug1023 | Co-mestring (co-coping) Wiki | 0.21 |
drug1724 | Fuzheng Huayu Tablet Wiki | 0.21 |
drug2037 | IN01 vaccine Wiki | 0.21 |
drug766 | CLIA of IgG and IgM against SARS-Cov-2 Wiki | 0.21 |
drug4867 | bovhyaluronidase azoxymer Wiki | 0.21 |
drug494 | BI 1015550 Wiki | 0.21 |
drug4804 | [18F]FP-R01-MG-F2 Wiki | 0.21 |
drug1252 | Darunavir Wiki | 0.21 |
drug1026 | Cobicistat Wiki | 0.21 |
drug2801 | Nintedanib Wiki | 0.21 |
drug696 | Brensocatib 25 mg Wiki | 0.21 |
drug2906 | ORIN1001 Wiki | 0.21 |
drug2357 | Liver function tests ,serum ferritin and PCR for COVID-19 . Wiki | 0.21 |
drug4852 | biological samples day of delivery Wiki | 0.21 |
drug2803 | Nintedanib 150 MG [Ofev] Wiki | 0.21 |
drug4578 | Unsupervised exercise Wiki | 0.21 |
drug4842 | bacTRL-Spike Wiki | 0.21 |
drug4901 | control Wiki | 0.21 |
drug44 | 20 Mg Prednisone for 14 days Wiki | 0.21 |
drug4843 | bamlanivimab Wiki | 0.21 |
drug757 | CHEST CT SCAN Wiki | 0.21 |
drug1491 | Emtricitabine/Tenofovir Alafenamide Wiki | 0.21 |
drug4259 | TD-1058 Wiki | 0.21 |
drug1255 | Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC Wiki | 0.21 |
drug4837 | autologous adipose-derived stem cells Wiki | 0.21 |
drug4838 | autopsy Wiki | 0.21 |
drug5187 | respiratory function rehabilitation training Wiki | 0.21 |
drug4691 | Vitamin C tablets Wiki | 0.21 |
drug495 | BI 1323495 Wiki | 0.21 |
drug1559 | Exercise Wiki | 0.12 |
drug2187 | Interview Wiki | 0.10 |
drug3195 | Placebo Wiki | 0.08 |
drug3495 | Questionnaire Wiki | 0.04 |
drug3273 | Placebo oral tablet Wiki | 0.04 |
Name (Synonyms) | Correlation | |
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D011658 | Pulmonary Fibrosis NIH | 0.55 |
D003550 | Cystic Fibrosis NIH | 0.43 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.38 |
Name (Synonyms) | Correlation | |
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D055732 | Pulmonary Aspergillosis NIH | 0.21 |
D015209 | Cholangitis, Sclerosing NIH | 0.21 |
D008103 | Liver Cirrhosis, NIH | 0.21 |
D001228 | Aspergillosis NIH | 0.21 |
D001229 | Aspergillosis, Allergic Bronchopulmonary NIH | 0.21 |
D001987 | Bronchiectasis NIH | 0.17 |
D009181 | Mycoses NIH | 0.15 |
D002761 | Cholangitis NIH | 0.15 |
D017563 | Lung Diseases, Interstitial NIH | 0.11 |
D008171 | Lung Diseases, NIH | 0.07 |
D012120 | Respiration Disorders NIH | 0.04 |
D012140 | Respiratory Tract Diseases NIH | 0.04 |
D011014 | Pneumonia NIH | 0.02 |
D003141 | Communicable Diseases NIH | 0.01 |
D007239 | Infection NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002206 | Pulmonary fibrosis HPO | 0.55 |
HP:0001395 | Hepatic fibrosis HPO | 0.21 |
HP:0002110 | Bronchiectasis HPO | 0.17 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0030151 | Cholangitis HPO | 0.15 |
HP:0006515 | Interstitial pneumonitis HPO | 0.11 |
HP:0002088 | Abnormal lung morphology HPO | 0.07 |
HP:0002090 | Pneumonia HPO | 0.02 |
Navigate: Correlations HPO
There are 22 clinical trials
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with [18F]FP-R01-MG-F2 with PET/CT
Description: The SUVmax in a lung or liver with known IPF, COVID19 pneumonia, or PSC respectively will be compared to the SUVmax in a known healthy lung/liver. It is expected that the SUV max, which is a measurement of the maximum value of radiopharmaceutical uptake within the region of interest (ROI) in IPF, COVID19 pneumonia, and PSC will be higher than the SUV max in the healthy lung/liver.
Measure: SUV max comparison : IPF versus Healthy Lung, PSC versus Healthy Liver, COVID19 versus Healthy Lung Time: an estimated average of 2 hoursDescription: Blood samples for blood time-activity measurements taken at 1, 3, 5, 10, 30, and 60 minutes after tracer injection for tracer kinetic analysis. Tracer kinetic analysis shows radiopharmaceutical distribution from the blood to the tissues over time.
Measure: Time Activity Measurements Time: an estimated average of 1 hoursDescription: EKG data, vital signs and laboratory data collected before IV injection of [18F]FP-R01-MG-F2 and after completion of the scan will allow the investigators to evaluate the safety and tolerability of the radiopharmaceutical. This will be measured as the number of patients who successfully completed the study.
Measure: Incidence of Study Completion (Safety and Tolerability) Time: an estimated average of 2 hoursPeople with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur. Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function. The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.
Description: Time taken after eating for ingested food to be identifiable at the caecum on MRI
Measure: Oro-caecal Transit Time Time: 1 day of scanningDescription: Volume of stomach at each time point of digestion to measure gastric emptying time
Measure: Gastric volume Time: 1 day of scanningDescription: Volume of water content in small bowel representing secretions and post prandial change in small bowel water content at T240 and T300
Measure: Small bowel water content (corrected for body surface area) Time: 1 day of scanningDescription: Volume of colon representing ease of chyme passage through colon
Measure: Colonic volume (corrected for body surface area) Time: 1 day of scanningDescription: Gastrointestinal symptoms measured by patient reported outcomes to monitor relationships with outcomes measure by MRI
Measure: Gastrointestinal symptoms Time: 1 day of scanningDescription: Volume of sigmoid colon
Measure: Sigmoid colon volume Time: 1 day of scanningDescription: An approximate measure of water content in chyme present in the ascending colon
Measure: T1 relaxation of ascending colon chyme Time: 1 day of scanningDescription: A measure of fat content in chyme present in the ascending colon
Measure: Fat fraction of ascending colon chyme Time: 1 day of scanningDescription: A measure of elastase in stool to evaluate pancreatic function
Measure: Faecal elastase Time: 1 dayDescription: A measure of microbiome in sputum and stool
Measure: Sputum and faecal microbiome Time: 1 dayDescription: A measure of intestinal inflammation
Measure: Faecal calprotectin Time: 1 dayDescription: A measure of motility at the terminal ileum using the GIQuant tool in arbitrary units
Measure: Terminal Ileum motility Time: 1 dayAccording to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
Description: Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.
Measure: The improvement proportion of pulmonary fibrosis Time: Week 24Description: Evaluation of Lung Function Improvement
Measure: Blood oxygen saturation Time: Week 24Description: Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19
Measure: Clinical symptom score Time: Week 24Description: This scale can reflect the quality of life of patients to some extent.
Measure: Quality of Life-BREF (QOL-BREF) Time: Week 24Description: This scale can reflect the quality of life of patients to some extent.
Measure: Patient Health Questionnaire-9(PHQ-9) Time: Week 24Description: This scale can reflect the quality of life of patients to some extent.
Measure: Generalized anxiety disorder-7(GAD-7) Time: Week 24Description: Evaluation of Lung Function Improvement
Measure: The 6-minute walk distance Time: Week 24COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Description: 7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis
Measure: All-cause mortality of COVID-19 patients with liver cirrhosis Time: From illness onset of COVID-19 to death from any cause, up to 365 daysDescription: 7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis
Measure: Liver-related mortality of COVID-19 patients with liver cirrhosis Time: From illness onset of COVID-19 to death from liver-related cause, up to 365 daysDescription: Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis
Measure: Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis Time: From hospital admission to death, up to 365 daysDescription: Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis
Measure: Baseline characteristics of COVID-19 patients with liver cirrhosis Time: 1 DayThis study aims to assess the effects of programmed exercise combined with CFTR protein modulator drugs in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis.
Description: Changes in strength will be measured using a five repetition maximum test (5RM)
Measure: Change in Strength Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Measure: Change in Cardiorespiratory Fitness Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1 will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory volume in 1 second (FEV1) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FVC will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced vital capacity (FVC) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEV1/FVC ratio (FEV1%) will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in FEV1/FVC ratio (FEV1%) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in FEF will be measured using Spirometry (z-score based on Global Lung Function Initiative reference DOI: 10.1016/j.arbres.2017.07.019)
Measure: Changes in Forced expiratory flow (FEF) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in physical activity levels will be measured using PAQ-C for children under 14 years of age and PAQ-A for adolescents over 14 years of age. Items 1 to 9 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-C activity summary score. Items 1 to 8 will be used in the physical activity composite score, and means will be calculated to obtain the final PAQ-A activity summary score. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Measure: Changes in Physical Activity Questionnaire (PAQ) for children and adolescents Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R). Scores for each health related quality of life domain are calculated; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measure: Change in quality of life: Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Time: Four assessment points throughout the study: baseline and after each 8-week interventionDescription: Chloride concentration in sweat (mEq/L) will be measured in the laboratory using an MK II Chloride Analyzer 926S
Measure: Sweat chloride level Time: Four assessment points throughout the study: baseline and after each 8-week interventionTo investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC). To investigate safety and tolerability of BI 1015550 in the overall trial population.
Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections. However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia. Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported. Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis. Therefore, generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding. The STOPPIT trial is the first prospective, randomized, controlled, double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy. Importantly, patients with an evidence-based indication for PPI therapy are excluded from the trial. All study participants (n=476) stop their previous PPI treatment and are then randomized (1:1) to receive either placebo (intervention group) or esomeprazole 20mg/day (control group) for 360 days. The primary hypothesis anticipates a delay of re-hospitalisation and/or death (composite endpoint) in patients who discontinue PPI treatment as compared to patients who continue PPI therapy. Secondary objectives include the assessment of mortality, re-hospitalisation rates, infection rates, rate of acute hepatic decompensation and ACLF, as well as rates of upper and lower gastrointestinal bleeding events in both groups. Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment.
Description: Infection rates by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus-infection, Sars-CoV-2-infection)
Measure: Infection rates differentiated by site Time: 360 days after randomizationDescription: The gut microbiota composition will be analyzed by PCR
Measure: Changes of intestinal microbiota between baseline and day 90 Time: 90 days after randomizationImpacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic
Description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),
Measure: Cancellation or postponement of consultations by the health professional or patient, Time: Up to 6 monthsDescription: Number of consultations cancelled by the teleconsultation/replacement patient,
Measure: Patient cancellation of teleconsultations/telecare replacement, Time: Up to 6 monthsDescription: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)
Measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled), Time: Up to 6 monthsDescription: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).
Measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration). Time: Up to 6 monthsDescription: Cancellation or postponement by the patient of consultations (medical or paramedical) Patient cancellation of teleconsultations/telecare proposed by the health professional Cancellation or postponement by the patient of hospitalizations (acute or scheduled)
Measure: The reduction of each of the elements of care provision and health care utilization: Time: Up to 6 monthsDescription: Intravenous instead of intravenous administration
Measure: The change of modality of administration of antibiotic cures Time: Up to 6 monthsDescription: Questionnaire about taking or not taking treatment during confinement
Measure: Compliance Time: Up to 6 monthsDescription: Scale 0-21
Measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well) Time: Up to 6 monthsDescription: A questionnaire on the presence or absence of toxic consumption
Measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown Time: Up to 6 monthsDescription: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)
Measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19 Time: Up to 6 monthsDescription: Role of social inequalities in the consequences of containment assessed by qualitative methods
Measure: Assessing the role of social inequalities in the consequences of lockdown Time: Up to 6 monthsDescription: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis
Measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis. Time: Up to 6 monthsThis study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.
Description: Difference in sputum Th2 biomarkers (ECP, IL4, IL5, IL10, IL13, and eosinophil count) in patients with CF with fungal infection with expected elevation of sputum Th2 biomarkers in patients with CF and ABPA compared to those without fungal infection and without ABPA.
Measure: Difference in Th2 Sputum Markers Time: Day 1Description: Serum Th2 biomarkers in patients with fungal infection and ABPA (Table 3). Serum Th1 biomarkers in patients with fungal infection and ABPA (Table 3). Serum sensitization markers to fungal allergens in patients with fungal infection and ABPA (Table 4). Baseline and historic lung function, historical comorbid diagnoses and BMI measurements in patients with fungal infection and ABPA. Environmental factors that are possibly related to fungal infection and ABPA in patients with CF. Immune profile: A profile of each group will be based upon their findings of each set of biomarkers: Th1, Th2, mold allergy panel, and systemic markers of inflammation. Based upon findings in each of these categories (elevated, depressed), we will be able to formulate a profile based upon the type of marker/inflammatory pathway.
Measure: Other markers of fungal inflammation and allergic reaction in patients with CF Time: Day 1Description: Banking of both sputum and serum to potentially utilize microbiome and transcriptome techniques for further immunotyping and infection characterization.
Measure: Biobanking of specimens Time: Day 1The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients. The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections. The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy". In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods. The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).
SARS-CoV-2 infection induces a hyperinflammatory syndrome, causing the acute respiratory distress syndrome, massive lung cell destruction and, as a plausible sequelae, pulmonary fibrosis in COVID-19 patients. Current focus has been on the development of novel immunosuppressant therapies, in order to control the cytokine storm in COVID-19 patients. Thus, the effect of steroids, intravenous immunoglobulin, non-steroidal immunosuppressants, selective cytokine blockade, JAK/STAT pathway inbhibition, and mesenchymal precursor cells have been evaluated. Based on the above information, we propose COLLAGEN-POLYVINYLPYRROLIDONE (Distinctive name: FibroquelMR, active substance: Collagen-polyvinylpyrrolidone, pharmaceutical form: intramuscular injectable solution, with sanitary registration No. 201M95 SSA IV and SSA code: 010 000 3999) as a potential drug for the downregulation of the cytokine storm. Polymerized type I collagen reduces the expression of IL-1β, IL-8, TNF-alpha, TGF-β1, IL-17, Cox-1, leukocyte adhesion molecules (ELAM-1, VCAM- 1 and ICAM-1), some other mediators of inflammation and increases the levels of IL-10 and the number of regulatory T cells. In addition, it promotes the mechanisms of inhibition of tissue fibrosis, without adverse effects in rheumatoid arthritis and osteoarthritis.
Description: It will be considered as primary outcome if the patients meet the first criterion, or 2 of the remaining 3: No oxygen required to maintain oxygen saturation more than 92%, Decrease in severity category from Table 1 by at least 1 level, or Reduction in the time of symptoms, by at least 30% compared to placebo and baseline, or recovery of at least 30% the number of lymphocytes compared to placebo and baseline.
Measure: Clinical primary Outcome measure Time: 14 daysDescription: It will be considered as secondary outcome if the patients meet the first criterion, or 2 of the remaining 3: significant decrease in serum IP-10 (at least 30% compared to placebo and baseline), since this chemokine is directly associated with the progression and severity of COVID-19, significant decrease in serum pro-inflammatory cytokines (TNF-a, IL-1β, IL-7, at least 30% compared to placebo and baseline), significant decrease in the percentage of circulating effector T cells (at least 30% compared to placebo and baseline), or significant improvement from computerized axial tomography at re-examination. This improvement is defined as: a decrease of at least 40% in parenchymal attenuation, the appearance of ground glass, nodular opacities, thickening of interlobular septa and / or thickening of bronchial walls.
Measure: Immunological secondary outcome measure Time: 3 monthsMethodology: This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection. Patients who give informed consent will be screened for enrolment in the study. Patients that meet the eligibility criteria will be enrolled and randomly allocated in the control arm (best standard of care) or the experimental arm (best standard of care plus IN01 vaccination). The patients enrolled in the control arm of the study will receive standard of care. The primary endpoint is safety, measured by the Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria. Biochemical and blood count alterations will be also monitored. Safety will be defined based on the frequency and severity of adverse events (AEs) throughout the patient's participation in the study comparing between control and experimental arms. Efficacy will be measured as function of the annual rate of decline in the Forced Vital Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52. High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12, 24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease. A translational substudy will be included. Objectives: Primary Objective ● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients that develop fibrotic lung syndrome after infection. Secondary Objectives - To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung disease after infection. - To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of action.
Description: Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria and hematological alterations that are clinical relevant under physician criteria. Data will be presented as number of AEs classified by severity.
Measure: Safety (Frequency/severity of AEs) Time: Through study completion, average 1 yearDescription: blood oxygen levels will be measured by a pulse oximeter
Measure: Oxygen saturation Time: baseline and days 1, 14 (w2), 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52Description: St George QoL questionnaire: Disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: Quality of life (QoL) Time: baseline and weeks 2, 12, 24, 36 and 52Description: High-resolution CT to follow fibrotic pattern reviewed by a central radiologist
Measure: Fibrotic pulmonary extension (measured as the size of the lesions) Time: baseline and weeks, 12, 24, and 52Currently, there is no approved treatment for COVID-19 in France, either for the acute phase, nor for the late chronic phase. the investigator suggest that nintedanib has the potential to block the development of lung fibrosis when initiated early enough to inhibit the activation of mesenchymal cells and the progression of virus-induced pulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrous stripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrous stripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye et al observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3 patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data are still lacking in patients with COVID-19 and the investigators do not know how many patients will have fibrotic sequelae from the acute illness.
Description: Change in Forced Vital Capacity over 12 months assessed by Annual Rate of Decline in FVC in Overall Population
Measure: The primary objective is to assess whether nintedanib slows the progression of lung fibrosis in COVID-19 survivors as assessed by the decline in the forced vital capacity (FVC) over 12 months compared to placebo. Time: at inclusion and 12 months.Description: Rate of decline in DLCO estimated by linear regression of DLCO from baseline to 12 months from DLCO measurement at inclusion, 6 and 12 months
Measure: compare the rate of decline of DLCO over 12 months Time: at inclusion, 6 and 12 monthsDescription: Absolute change from baseline in the Six-minute walk test (6MWT) at 12 months
Measure: compare exercise capacity at 12 months Time: at 12 monthsDescription: HRCT fibrosis score and HRCT fibrosis extension (visual and computer-based assessment) at inclusion and 12 months
Measure: compare high resolution CT (HRCT) lung opacities extension at 12 months Time: at inclusion and 12 monthsDescription: Absolute change from baseline in the total score on the St. George's Respiratory Questionnaire questionnaire at 12 months
Measure: compare change in health-related quality of life Time: at 12 monthsDescription: Absolute change from baseline in the Dyspnea score (Multidimensional Dyspnea Profile and mMRC score) at 3, 6, 9 and 12 months
Measure: compare the evolution of dyspnea over time Time: at 3, 6, 9 and 12 monthsDescription: The absolute change from baseline Hospital Anxiety and Depression score at 3, 6, 9 and 12 months
Measure: compare change in Depression and anxiety over time Time: at 3, 6, 9 and 12 monthsDescription: Biomarker assay (KL-6, NT-proBNP, CRP, D-dimers) at inclusion and 12 months
Measure: compare change in lung injury, pulmonary hypertension and inflammation biomarkers Time: at inclusion and 12 monthsDescription: Percentage of patients with a tricuspid regurgitation velocity > 2.5, 2.8 and 3.4 m/sec evaluated at baseline and at 12 months.
Measure: pulmonary hypertension prevalence at inclusion and 12 months Time: at inclusion and 12 monthsDescription: MUC5B at risk allele detection at inclusion
Measure: association between genetic susceptibility (MUC5B polymorphism) and lung fibrosis in COVID-19 survivors Time: at inclusionDescription: Incidence of clinical or biological adverse events with nintedanib versus placebo over 12 months
Measure: safety of nintedanib Time: over 12 monthsA randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates
Description: resolution of CT chest infiltrates as evaluated by radiologest on a score of no infiltrates, <5%, 5-25%and >25 % infiltrates
Measure: improved Time: 14 daysThe purpose of this study is to validate and utilize a personalized medicine approach to identify potential treatments with current FDA approved CFTR modifiers for non-approved CF gene mutations. The study will perform ex vivo testing of CFTR function and current marketed CFTR modulating drugs on expanded nasal cells at Cincinnati Children's Human Nasal Epithelium (HNE) Core Laboratory. The results will be confirmed and translated into bedside care through an N of 1 trial to determine effectiveness of treatment.
Description: Absolute change in ppFEV1 of 5% or greater
Measure: ppFEV1 Time: 16 weeksThis is a Phase 1, 3-part, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1058 inhaled solution. Part A is a SAD study in healthy subjects, Part B is a MAD study in healthy subjects, and Part C is a multiple-dose study in subjects with IPF.
Description: Number and severity of treatment emergent adverse events
Measure: Part A (SAD) - Adverse Events Time: Part A (SAD) Day 1 to Day 8Description: Number and severity of treatment emergent adverse events
Measure: Part B (MAD) - Adverse Events Time: Part B (MAD) Day 1 to Day 21Description: Number and severity of treatment emergent adverse events
Measure: Part C (IPF) - Adverse Events Time: Part C (IPF) Day 1 to Day 35Description: Multiple PK variables of TD-0903 will be assessed during Part A, B and C and may include, but are not limited to: Area under the plasma concentration-time curve (AUC)
Measure: Pharmacokinetics (PK) of TD-1058: AUC Time: Part A (SAD) Day 1 to Day 8 Part B (MAD) Day 1 to Day 21 Part C (IPF) Day 1 to Day 35Description: Multiple PK variables of TD-0903 will be assessed during Part A, B and C and may include, but are not limited to: Maximum observed concentration (Cmax)
Measure: Pharmacokinetics (PK) of TD-1058: Cmax Time: Part A (SAD) Day 1 to Day 8 Part B (MAD) Day 1 to Day 21 Part C (IPF) Day 1 to Day 35Description: Multiple PK variables of TD-0903 will be assessed during Part A, B and C and may include, but are not limited to: Time to reach maximum observed concentration (Tmax)
Measure: Pharmacokinetics (PK) of TD-1058: Tmax Time: Part A (SAD) Day 1 to Day 8 Part B (MAD) Day 1 to Day 21 Part C (IPF) Day 1 to Day 35The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
This is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.
Description: Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Measure: Change in Forced Vital Capacity (FVC) Time: Baseline and 180 daysDescription: Death within 90 days and 180 days from enrollment due to a respiratory cause
Measure: Number of deaths due to respiratory cause Time: within 90-180 daysDescription: Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.
Measure: Chest CT visual score Time: 180 daysDescription: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: St. George's Respiratory Questionnaire (SGRQ) Time: Day 90Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: St. George's Respiratory Questionnaire (SGRQ) Time: Day 180Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Measure: King's Brief Interstitial Lung Disease (KBILD) Time: Day 90Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Measure: King's Brief ILD (KBILD) Time: Day 180Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.
Measure: Leicester Cough Questionnaire (LCQ) Time: Day 90Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.
Measure: Leicester Cough Questionnaire Time: Day 180Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.
Measure: Short Form (SF) 36 Health Survey Time: Day 90Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.
Measure: SF 36 Health Survey Time: Day 180Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 90Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 180Description: Number of participants with Increase in liver transaminases
Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal Time: day 90Description: Number of participants with Increase in liver transaminases
Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal Time: day 180Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 90Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 180Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 90Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 180Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Measure: Number of participants with GI events Time: day 90Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Measure: Number of participants with GI events Time: day 180Cystic fibrosis (CF) affects men and women equally, but after the onset of puberty, women with CF have a lower life expectancy than men with CF. Despite these known differences, the link between CF symptom trends and the menstrual cycle remains critically understudied. To address this gap, this study will investigate changes in CF-specific symptoms among women with CF to evaluate whether and how they correlate with their menstrual cycle. Specifically, the investigators hope to examine whether CF-related symptoms change throughout the menstrual cycle, what the impact of those symptoms is on quality of life, and how feasible it is to use a period tracking app to track CF-related symptoms throughout the menstrual cycle. Investigators are asking women ages 18-45 with CF, who have regular menstrual cycles, to participate. Study procedures, including online surveys, period tracking, and interview, will take approximately 3 months.
Description: Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measure: Average change of Cystic Fibrosis-related pulmonary symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal) Time: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollmentDescription: Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measure: Average change of Cystic Fibrosis-related sinus symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal) Time: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollmentDescription: Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measure: Average change of Cystic Fibrosis-related rheumatic symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal) Time: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollmentDescription: Rating of Mild, Moderate, or Severe in the Clue smartphone app
Measure: Average change of Cystic Fibrosis-related gastrointestinal symptoms from baseline for each of the four phases of the menstrual cycle (menses, follicular, ovulation, and luteal) Time: 3 consecutive menstrual cycles (each cycle is 28 days) following enrollmentThis Phase 1b trial is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of oral ORIN1001 at 25 mg, 50 mg or 100 mg administered daily for up to 28 days in adult subjects with idiopathic pulmonary fibrosis (IPF) alone or in conjunction with local Standard of Care for IPF (pirfenidone or nintedanib). A maximum of 24 evaluable subjects will be required to complete the study. The study will consist of 3 dose cohorts each enrolling a maximum of 8 subjects randomized either to the active (5 subjects) group or placebo (3 subjects) group. Each subject will receive daily oral doses of ORIN1001 or placebo for 28 days. The safety and pharmacokinetic profile will be evaluated in this study and will include cardiovascular and pulmonary endpoints.
Description: measurement of blood pressure
Measure: Blood pressure Time: Up to 60 daysDescription: measurement of heart rate
Measure: Heart Rate Time: Up to 60 daysDescription: Measurement of respiratory rate
Measure: Respiratory Rate Time: Up to 60 daysDescription: Measurement of body temperature
Measure: Body Temperature Time: Up to 60 daysDescription: Cardiovascular evaluation to determine intervals including QTc interval
Measure: 12-lead ECG Time: Up to 60 daysDescription: ALT, albumin, ALP, AST, BUN, Ca, Cl, Cholesterol, Creatinine, CK, CA, Elastase, GGT, glucose, HDL, LDH, lipase, LDL, phosphorus, sodium, Total bilirubin, Total protein, Triglycerides, Uric acid, Lipid panel
Measure: Serum Clinical Chemistry analysis Time: Up to 60 daysDescription: WBC, RBC, Hb, HCT, MCV, MCH, MCHC, Neu, Lymphocytes, EOS, Bas, PLT
Measure: Whole blood Hematology analysis Time: Up to 60 dysDescription: PT, APTT, INR
Measure: Whole blood Coagulation Parameters Time: Up to 60 daysDescription: Bilrubin, glusoe, ketones, leukocytes, nitrite, blood, pH, specific gravity, protein, urobilinogen
Measure: Urinalysis Time: Up to 60 daysDescription: Evaluation of other medications taken currently with investigative drug
Measure: Concomitant medications Time: Up to 60 daysDescription: Medical Health examination, medical history, medicine history, reproductive history, baseline information
Measure: Physical examination Time: Up to 60 daysDescription: Body weight in kg
Measure: Body weight Time: Up to 60 daysDescription: Pulmonary Function Tests: Forced vital capacity (FVC), Forced expiratory volume (FEV)
Measure: Spirometry Time: Up to 60 daysDescription: Height in cm
Measure: Height Time: Up to 60 daysDescription: Calculation of BMI using weight (kg) and height (cm)
Measure: Body mass index (BMI) Time: Up to 60 daysDescription: Lung test to assess diffusion capacity
Measure: DLCO - Assessment of diffusion capacity Time: Up to 60 daysDescription: Blood collection for evaluation of ORIN1001 exposure. Measurements will assess half life, exposure, maximum concentration, time to maximum concentration and accumulation ratios
Measure: Blood collection to measure drug concentration over time Time: Up to 29 daysDescription: Blood collection for evaluation of disease biomarker of lung fibrosis: SP-D, MMP-7 and KL6. Specific biomarker to be determined
Measure: Exploratory biomarkers to evaluate lung fibrosis Time: Up to 60 daysDescription: Questionnaire to assess the quality of life during the study period
Measure: Quality of Life Questionnaire Time: Up to 60 daysDescription: Blood collection for evaluation of inflammation such as cytokines TGF-B and/or IL-6
Measure: Exploratory biomarkers to evaluate inflammation Time: Up to 60 daysA study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of post-inflammatory pulmonary fibrosis and interstitial lung disease following COVID-19.
Description: The severity of pulmonary tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group according to the results of a blinded central laboratory
Measure: The severity of lung tissue lesions with fibrosis and interstitial changes on day 75 Time: Day 0, Day 75Description: The severity of lung tissue damage by fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 6 months in relation to the baseline values of the indicator in patients of the Longidaze® group in comparison with the the dynamic observation group (according to the results of a blinded central laboratory)
Measure: The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180 Time: Day 0, Day 180Description: The severity of lung tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group (according to the results of the local laboratory)
Measure: The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180 Time: Day 0, Day 75, Day 180Description: The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) based on the high-resolution computed tomography images analyzed by the Botkin.AI program (artificial intelligence) and then verified by a specialist after 2.5 months and 6 months from the beginning of observation in relation to the baseline values of indicators in patients of the Longidaze® group in comparison with the dynamic observation group
Measure: The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) images analyzed by the Botkin.AI program (artificial intelligence) Time: Day 75, Day 180Description: Change in forced vital capacity FVC (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group
Measure: Change in forced vital capacity (FVC) Time: Day 0, Day 75, Day 180Description: Change in the diffusion capacity of the lungs (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group
Measure: Change in the diffusion capacity of the lungs Time: Day 0, Day 75, Day 180Description: Change in the degree of dyspnea on the MMRC scale from baseline after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. MMRC scale (Modified Medical Research Council scale) 0 - no - Dyspnea does not bother, except for very intense exercise - mild - Shortness of breath bothers with brisk walking or climbing a small elevation - moderate to severe - Shortness of breath results in slower walking compared to other people of the same age, or need to stop while walking at normal pace on a level surface - Severe - Shortness of breath makes you stop when walking about 100 m or after a few minutes of walking on a flat surface - very severe - Shortness of breath makes it impossible to leave the house or appears when dressing and undressing
Measure: Change in the degree of dyspnea on the MMRC scale Time: Day 0, Day 75, Day 180Description: Changes in SpO2 of capillary blood relative to the initial value after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Changes in capillary blood oxygen saturation (SpO2) Time: Day 0, Day 75, Day 180Description: Changes in the covered footage in the 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Changes in the covered footage in the 6-minute walk test Time: Day 0, Day 75, Day 180Description: Changes in capillary blood saturation (SpO2) after a 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Changes in capillary blood saturation (SpO2) after a 6-minute walk test Time: Day 0, Day 75, Day 180Description: Change in the residual volume of the lungs after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Change in the residual volume of the lungs Time: Day 0, Day 75Description: Change in the total lung capacity after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Change in the total lung capacity Time: Day 0, Day 75Description: Change in inspiratory capacity after 2.5 months in patients of the Longidaze® group compared with dynamic observation group
Measure: Change in inspiratory capacity Time: Day 75This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis. The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but do not contain any medicine. Participants can also continue taking standard medicines for noncystic bronchiectasis throughout the study. Participants are in the study for about 4 months. During this time, the participants visit the study site about 11 times and get about 2 phone calls. At the visits, doctors check the health of the participants and note any health problems that could have been caused by BI 1323495.
Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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