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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4532 | insurance navigation Wiki | 0.28 |
| drug2422 | Mometasone furoate Wiki | 0.28 |
| drug377 | Asthma reliever therapies Wiki | 0.28 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2339 | Mepolizumab 100 MG [Nucala] Wiki | 0.28 |
| drug3773 | Standart Care given during normal examination Wiki | 0.28 |
| drug713 | CNM-ZnAg Wiki | 0.28 |
| drug709 | CLBS119 Wiki | 0.28 |
| drug2432 | Montelukast Oral Granules Wiki | 0.28 |
| drug2429 | Monodose RS01 Wiki | 0.28 |
| drug547 | Best Standard of Care + CARDIO Wiki | 0.28 |
| drug376 | Asthma controller therapies (incl. prednisone/prednisolone) Wiki | 0.28 |
| drug704 | CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) Wiki | 0.28 |
| drug3166 | QMF149 Wiki | 0.28 |
| drug722 | COVI-GUARD Wiki | 0.28 |
| drug715 | COM-COVID anonimous survey Wiki | 0.28 |
| drug710 | CLIA of IgG and IgM against SARS-Cov-2 Wiki | 0.28 |
| drug728 | COVID 19 diagnostic test by PCR Wiki | 0.28 |
| drug726 | COVID 19 Diagnostic Test Wiki | 0.28 |
| drug1284 | Dupilumab (SAR231893/REGN668) Wiki | 0.28 |
| drug4268 | Voriconazole Inhalation Powder Wiki | 0.28 |
| drug1696 | Health Promotion Program with cartoon education for Children with Asthma Wiki | 0.28 |
| drug723 | COVI-VAC Wiki | 0.28 |
| drug1616 | GSK3923868 Wiki | 0.28 |
| drug718 | CONVALESCENT PLASMA Wiki | 0.28 |
| drug721 | COVI-AMG Wiki | 0.28 |
| drug708 | CK0802 Wiki | 0.28 |
| drug546 | Best Standard of Care Wiki | 0.28 |
| drug4656 | placebo rinse Wiki | 0.28 |
| drug4270 | WEB BASED EDUCATION Wiki | 0.28 |
| drug2231 | MEDI3506 Wiki | 0.20 |
| drug3968 | Tezepelumab Wiki | 0.20 |
| drug731 | COVID Convalescent Plasma Wiki | 0.20 |
| drug2296 | Matching placebo Wiki | 0.14 |
| drug2916 | Placebo Wiki | 0.10 |
| drug3728 | Standard of Care Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011657 | Pulmonary Eosinophilia NIH | 0.39 |
| D001982 | Bronchial Diseases NIH | 0.28 |
| D006969 | Hypersensitivity, Immediate NIH | 0.28 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012130 | Respiratory Hypersensitivity NIH | 0.28 |
| D006967 | Hypersensitivity, NIH | 0.12 |
| D007154 | Immune System Diseases NIH | 0.11 |
| D008173 | Lung Diseases, Obstructive NIH | 0.07 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.07 |
| D053120 | Respiratory Aspiration NIH | 0.07 |
| D008171 | Lung Diseases, NIH | 0.06 |
| D012140 | Respiratory Tract Diseases NIH | 0.05 |
| D007249 | Inflammation NIH | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002099 | Asthma HPO | 1.00 |
| HP:0012393 | Allergy HPO | 0.12 |
| HP:0006536 | Pulmonary obstruction HPO | 0.07 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.07 |
| HP:0002088 | Abnormal lung morphology HPO | 0.06 |
Navigate: Correlations HPO
There are 13 clinical trials
Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to standard treatment in children with moderate and severe acute exacerbations improves outcomes. Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged 5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung function, clinical severity, hospitalization rate and 72-hour symptom burden. Secondary Hypotheses: 1. There are greater effects of high-dose oral montelukast on lung function and on the secondary outcomes in the presence of respiratory viral detection or leukotriene-mediated inflammation; and 2. There is an interaction between viral detection and urinary leukotriene 4 level with treatment-response. Design: A two-arm, parallel randomized controlled trial of high-dose oral montelukast versus identical placebo, as add-on to standard treatment of systemic corticosteroid (SCS) and inhaled short-acting Beta-2-agonist (SABA), in children aged 5 to 17 years with moderate and severe acute asthma exacerbations. Intervention: High-dose oral montelukast added to standard treatment as one treatment-allocation arm, in comparison with standard treatment as the 2nd treatment-allocation arm. Primary and Important Secondary Endpoints: For the Primary Aim, the primary outcome measure to be compared between arms will be change of %-predicted airway resistance by impulse oscillometry (IOS) at 5Hz (%R5) at 2 hours after treatment initiation. Secondary outcomes will include improvement of %-predicted FEV1 (%FEV1), clinical severity measured using the validated Acute Asthma Intensity Research Score (AAIRS), hospitalization rate, and 72 hour symptom burden using the Pediatric Asthma Caregiver Diary (PACD). For the Secondary Aim, the investigators will determine (1) The effects of high-dose oral montelukast on lung function and on our secondary outcomes in the presence of nasal viruses and of greater leukotriene-mediated inflammation; and (2) The degree of interaction between viral detection and urinary leukotriene E4 (LTE4) level with treatment-response. Laboratory evaluations: The primary outcome (change of %R5) and select secondary outcomes (%FEV1, AAIRS, LTE4) will be measured before and again at 2 hours after treatment initiation. The other secondary outcomes will be measured at the time of hospitalization decision-making by the clinical team (hospitalization rate) or at 72-hours after treatment initiation (PACD).
Description: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometrypost montelukast or control administration
Measure: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry Time: Before and 2-hours after treatment with montelukast or placeboDescription: Change of percent-predicted forced expiratory volume in 1-second (FEV1)
Measure: Change of percent-predicted forced expiratory volume in 1-second (FEV1) Time: Before and 2-hours after treatment with montelukast or placeboDescription: Change of the Acute Asthma Intensity Research Score (AAIRS)
Measure: Change of the Acute Asthma Intensity Research Score (AAIRS) Time: Before and 2-hours after treatment with montelukast or placeboDescription: Leukotriene E4 (LTE4)
Measure: Leukotriene E4 (LTE4) Time: Before treatment with montelukast or placeboDescription: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)
Measure: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD) Time: Before and at 72-hours after treatment with montelukast or placeboDescription: Hospitalization rate
Measure: Hospitalization rate Time: 8-hours after treatment with montelukast or placeboPrimary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.
Description: The number (n) and percentage (%) of patients experiencing any TEAE
Measure: Treatment-emergent adverse events (TEAEs) Time: From Day 1 up to Week 64Description: Annualized rate of severe asthma exacerbation events, during the treatment period
Measure: Severe asthma exacerbation events Time: From Day 1 up to Week 52Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
Measure: Change in % predicted FEV1 Time: From Day 1 up to Week 64Description: Change in absolute FEV1 - Clinically significant changes from baseline
Measure: Change in absolute FEV1 Time: From Day 1 up to Week 64Description: Change in forced vital capacity (FVC)
Measure: Change in FVC Time: From Day 1 up to Week 64Description: Change in forced expiratory flow (FEF) 25-75%
Measure: Change in FEF Time: From Day 1 up to Week 64Description: Serum dupilumab concentrations - Changes from first dupilumab injection
Measure: Assessment of dupilumab concentration Time: From Day 1 up to Week 64Description: Titers of Anti-dupilumab antibodies
Measure: Assessment of immunogenicity Time: From Day 1 up to Week 64Description: Blood: Eosinophil count
Measure: Assessment of blood Eosinophil count Time: From Day 1 up to Week 64Description: Serum: total IgE
Measure: Assessment of total immunoglobulin E (IgE) Time: From Day 1 up to Week 64A 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.
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.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.Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration.The objectives of this randomized, open-label, parallel study is to investigate the safety and efficacy of CARDIO plus best standard-of-care in reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality in hospitalized former smoker and steroid-resistant asthma patients with COVID-19 infection.
Description: Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (oxygen saturation rates) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (supplemental Oxygen) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (ventilator support) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Assessed by the National Early Warning Score (NEWS) which is a standardized tool that assesses disease severity and monitoring of patients in hospital. An aggregate score of respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature and the score is increased if supplemental oxygen is required. Each parameter is based on a scale of 0 - 3. 0=good, 3=poor
Measure: Clinical improvement Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Assessed by the WHO Ordinal Scale for Clinical Improvement which examines changes in clinical status and/or survival specific to COVID-19. This 8-point scale measures illness severity over time. 0 = no infection and 8 = dead
Measure: Clinical status Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.
Measure: Serial chest CT or X-ray findings Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours
Measure: Time to clinical recovery Time: Day 28 from baseline or day of dischargeDescription: increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2
Measure: Time to improvement in oxygenation for at least 48 hours Time: Day 28 from baseline or day of dischargeDescription: The number of days from hospital admission to hospital discharge
Measure: Hospitalization period Time: Day 28 from baseline or day of dischargeDescription: The total number of days on ventilator
Measure: Amount of time on Ventilator Time: Day 28 from baseline or day of dischargeDescription: number of days in intensive care unit (ICU)
Measure: Intensive Care stay Time: Day 28 from baseline or day of dischargeDescription: assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree
Measure: Quality of life (QoL) Time: Day1, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Death due to COVID-19 and other reasons
Measure: All-cause mortality Time: Day 28 from baseline or day of dischargeDescription: Body temperatures
Measure: Temperature measurements Time: Day 28 from baseline or day of dischargeDescription: measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.
Measure: Oxygen saturation measurements Time: Day 28 from baseline or day of dischargeDescription: assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree
Measure: COVID-19 QoL measurements Time: Day 28 from baseline or day of dischargeDescription: Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)
Measure: Adverse Events Time: During 15 days of supplementation or until day of discharge and during home follow upDescription: systolic and diastolic
Measure: Blood pressure Time: From baseline to 28 days thereafterDescription: Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using
Measure: Heart rate Time: Everyday From baseline to 28 days thereafterDescription: Frequency of clinically significant laboratory abnormalities.
Measure: Abnormality in laboratory tests Time: Day 28 from baseline or day of dischargeDescription: BMI values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Body mass Index (BMI) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: CBC values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Complete blood count (CBC) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: AST values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Aspartate transaminase (AST) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: ALT values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Alanine transaminase (ALT) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: ALP values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Alkaline phosphatase (ALP) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Bilirubin values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Bilirubin Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Sodium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Sodium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Potassium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Potassium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Chloride ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Chloride ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Creatinine values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Creatinine Time: Daily From baseline to 28 days thereafterDescription: eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: eGFR Time: Daily From baseline to 28 days thereafterDescription: HbA1c values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: HbA1c Time: Daily From baseline to 28 days thereafterDescription: eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Glucose Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: CRP value only taken at baseline for every participant
Measure: C-Reactive protein (CRP) Time: Baseline onlyObjective: The aim of this study is to determine the effect of the education program (HPPCA - Health Promotion Program for Children with Asthma), which was developed by using cartoons and comic based on the health promotion model of Nola J Pender and brain-based learning theories, on disease control and life quality in children aged between 7 and 11, and diagnosed with asthma. Materials and Methods: The sample of the study consisted of 74 children between the ages of 7 and 11, who presented to a respiratory disease unit of a university hospital in Istanbul. Children were randomly assigned to the experimental (38 children) and control (36 children) groups using the Urn method. It was administered to both groups prior to the intervention. After the HPPCA education administered only to the experimental group, both groups were administered two post-tests as a follow-up in the 1st and 3rd months. Standardized sociodemographic question form, Childhood Asthma Control Test (C-ACT) and Paediatric Asthma Quality of Life Questionnaire (PAQLQ) were used for the follow-up. The data were evaluated using statistical parametric tests.
Description: The questionnaire has three sub-dimensions, which are symptoms, activity limitation and emotional function. The items related to the "Symptoms" sub-dimension are the items 4, 6, 8, 10, 12, 14, 16, 18, 20 and 23. The items 1, 2, 3, 19 and 22 are related to the "Activity Limitation" sub-dimension. Finally, the items 5, 7, 9, 11, 13, 15, 17 and 21 are related to the "Emotional Function" sub-dimension. While applying the questionnaire, the child should be alone. In the questionnaire, the value of each question is between 1 and 7 points, and the score weights of the questions are equal. The lowest score that could be obtained from the scale is 23, and the highest score is 161. The scores of all sub-categories are added together and the mean scores are calculated. Higher score indicates better quality of life
Measure: Paediatric Asthma Quality of Life Questionnaire - PAQLQ Time: Pre TestDescription: The scale consists of two parts. The 4 questions asked in the first part are in VAS (visual analogue scale) type, and have 4 pictorial options. These questions are asked directly to the child and scored between 0 and 3. The remaining 3 questions are 6-Point Likert-type questions. They are reversely scored, from 5 to 0. This part has to be filled out by the parent. A score between 0 and 27 can be obtained on the scale. The cut-off point for the scale is 19. A score of 19 points or less obtained from the scale indicates that the asthma is not under control of the child.
Measure: Childhood Asthma Control Test Time: Pre TestDescription: The scale consists of two parts. The 4 questions asked in the first part are in VAS (visual analogue scale) type, and have 4 pictorial options. These questions are asked directly to the child and scored between 0 and 3. The remaining 3 questions are 6-Point Likert-type questions. They are reversely scored, from 5 to 0. This part has to be filled out by the parent. A score between 0 and 27 can be obtained on the scale. The cut-off point for the scale is 19. A score of 19 points or less obtained from the scale indicates that the asthma is not under control of the child.
Measure: Childhood Asthma Control Test-Change from Pre Test on first month Time: 1st monthDescription: The questionnaire has three sub-dimensions, which are symptoms, activity limitation and emotional function. The items related to the "Symptoms" sub-dimension are the items 4, 6, 8, 10, 12, 14, 16, 18, 20 and 23. The items 1, 2, 3, 19 and 22 are related to the "Activity Limitation" sub-dimension. Finally, the items 5, 7, 9, 11, 13, 15, 17 and 21 are related to the "Emotional Function" sub-dimension. While applying the questionnaire, the child should be alone. In the questionnaire, the value of each question is between 1 and 7 points, and the score weights of the questions are equal. The lowest score that could be obtained from the scale is 23, and the highest score is 161. The scores of all sub-categories are added together and the mean scores are calculated. Higher score indicates better quality of life
Measure: Pediatric Asthma Quality of Life Questionnaire - Change from Pre Test on first month Time: 1st monthDescription: The scale consists of two parts. The 4 questions asked in the first part are in VAS (visual analogue scale) type, and have 4 pictorial options. These questions are asked directly to the child and scored between 0 and 3. The remaining 3 questions are 6-Point Likert-type questions. They are reversely scored, from 5 to 0. This part has to be filled out by the parent. A score between 0 and 27 can be obtained on the scale. The cut-off point for the scale is 19. A score of 19 points or less obtained from the scale indicates that the asthma is not under control of the child.
Measure: Childhood Asthma Control Test-Change from pretest, first month and fourth month Time: 4th monthDescription: The questionnaire has three sub-dimensions, which are symptoms, activity limitation and emotional function. The items related to the "Symptoms" sub-dimension are the items 4, 6, 8, 10, 12, 14, 16, 18, 20 and 23. The items 1, 2, 3, 19 and 22 are related to the "Activity Limitation" sub-dimension. Finally, the items 5, 7, 9, 11, 13, 15, 17 and 21 are related to the "Emotional Function" sub-dimension. While applying the questionnaire, the child should be alone. In the questionnaire, the value of each question is between 1 and 7 points, and the score weights of the questions are equal. The lowest score that could be obtained from the scale is 23, and the highest score is 161. The scores of all sub-categories are added together and the mean scores are calculated. Higher score indicates better quality of life
Measure: Pediatric Asthma Quality of Life Questionnaire - Change from pretest, first month and fourth month Time: 4th monthDescription: If child don't go to the school because of the asthma attack. The investigators evaluate it with a question. The investigators' question was; Have participants ever been absent from school due to asthma in the last four weeks' And the child answer it yes or no
Measure: Number of School absenteeism Time: Pre TestDescription: unplanned outpatient clinic visits and emergency room visits. The investigators ask a question to parents; Have participants applied for an unplanned hospital admission due to asthma in the last four weeks?
Measure: Number of Hospital Visits Time: Pre TestDescription: If child don't go to the school because of the asthma attack. And the investigators evaluate the change for school absenteeism with new question; Have participants ever been absent from school due to asthma in the last eight weeks. And this is a yes or no question.
Measure: Number of School absenteeism -Change from Pre Test on first month Time: 1st monthDescription: unplanned outpatient clinic visits and emergency room visits.Have participants applied for an unplanned hospital admission due to asthma in the eight weeks? They should answer it yes or no.
Measure: Number of Hospital Visits -Change from Pre Test on first month Time: 1st monthDescription: If child don't go to the school because of the asthma attack. The investigators ask the question again; Have participants been absent from school due to asthma in the last four months? And the child should answer it yes or no.
Measure: Number of School absenteeism -Change from pretest to first month and fourth month Time: 4th monthDescription: unplanned outpatient clinic visits and emergency room visits. The investigators ask them a question; Have participants applied for an unplanned hospital admission due to asthma in the last four months? The investigators expect them to answer it yes or no.
Measure: Number of Hospital Visits-Change from pretest, first month and fourth month Time: 4th monthStudy D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.
Description: To assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Change from baseline to Week 16 in pre-BD FEV1 (L) Time: From Baseline to Week 16Description: To assess the PK of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma
Measure: Serum MEDI3506 concentration-time profiles from Study Day 1 until Study Day 169 Time: from Study Day 1 to Study Day 169 for a total of 24 weeksDescription: To assess the immunogenicity of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma.
Measure: ADA during the intervention and follow-up periods Time: from Study Day 1 to Study Day 169 for a total of 24 weeksDescription: To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Change from baseline to Week 16 in ACQ-6 score. Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe
Measure: Proportion of participants with a decrease in ACQ-6 score of ≥ 0.5 from baseline to Week 16 Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe
Measure: Proportion of participants achieving ACQ-6 well controlled status (defined as ACQ-6 score ≤ 0.75 at Week 16) Time: Week 16Description: To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Change from baseline in SGRQ at Week 16 Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Proportion of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16. Time: Baseline to Week 16Description: To further assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma
Measure: Change from baseline to Weeks 8 and 16 in post-BD FEV1 (L) Time: From baseline to Weeks 8 and 16Description: To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma
Measure: Time to first CompEx event based on the period from baseline to Week 16 Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Annualised CompEx event rate Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on concentration of FeNO in adult participants with uncontrolled moderate-to-severe asthma
Measure: Percent change from baseline to Week 16 in concentration of FeNO in exhaled breath Time: From baseline to Week 16This is a Phase 1b, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetic profiles of voriconazole inhalation powder in adult subjects with well-controlled asthma. This study will involve 2 cohorts.
Description: Frequency of AEs, SAEs, and discontinuations due to AEs
Measure: Number of participants who experience Adverse Events (AEs), Serious Adverse Events (SAEs) and withdrawals due to AEs Time: Through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant vital sign values
Measure: Number of participants who experience vital sign abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant pulse oximetry values
Measure: Number of participants who experience pulse oximetry abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FEV1 lung function
Measure: Mean change from baseline in forced expiratory volume (FEV1) Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FVC lung function
Measure: Mean change from baseline in forced vital capacity (FVC) Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FVC and FEF25-75% lung function
Measure: Mean change from baseline in forced expiratory flow over the middle 1/2 of the FVC (FEF25-75%) Time: Baseline through study completion, an average of 14 daysDescription: Spirometry used to measure FEV1 and FVC lung function
Measure: Mean change from baseline in FEV1/FVC ratio Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant ECG values
Measure: Mean change from baseline in QTcF changes via ECG Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant physical examination findings
Measure: Number of participants who experience physical examination abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Number of participants with potentially clinically significant laboratory test results
Measure: Number of participants who experience laboratory test abnormalities Time: Baseline through study completion, an average of 14 daysDescription: Blood samples will be collected for plasma analysis
Measure: PK of VIP in plasma: Area under the plasma-concentration time curve (AUC) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Area under the plasma-concentration time curve over the first 12 hours after dosing (AUC0-12) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Area under the concentration time curve, from time 0 to the last observed non-zero concentration (AUC0-tlast) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Area under the concentration time curve from time 0 extrapolated to infinity (AUC∞) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Maximum observed concentration (Cmax) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Time to maximal observed concentration (tmax) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Termination elimination half-life (t½) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Apparent total body clearance (CL/F) Time: Predose Day 1 and through 12 hours post last dose (day 4)Description: Blood samples will be collected for analysis
Measure: PK of VIP in plasma: Apparent volume of distribution during the terminal elimination phase (Vz/F) Time: Predose Day 1 and through 12 hours post last dose (day 4)This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.
Description: AEs and SAEs will be collected.
Measure: Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: AEs and SAEs will be collected.
Measure: Part B: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 18Description: AEs and SAEs will be collected.
Measure: Part C: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of hematology laboratory (lab) parameters.
Measure: Part A: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part A: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part A: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part B: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part B: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part B: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part C: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part C: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part C: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part A: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part B: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 18Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part C: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 8Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT intervals (QTc). The QT interval will be corrected for heart rate by Fredericia's formula (QTcF).
Measure: Part A: Number of participants with clinically significant abnormalities in 12-Lead electrocardiogram (ECG) findings Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part B: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 18Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part C: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 8Description: Spirometry measurements including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be assessed
Measure: Part A: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part B: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 18Description: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part C: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to last quantifiable concentration (AUC[0-t]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentration of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to infinity (AUC[0-inf]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Maximum observed GSK3923868 plasma concentration (Cmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Time to maximum observed plasma drug concentration (Tmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: AUC from time 0 (predose) to time tau (AUC [0-tau]) (tau=24hours for once a day dosing regimen) of GSK3923868 on Day 1 and Day 14 Time: Day 1 and 14: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Cmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Tmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: AUC (0-tau) (tau=24hours for once a day dosing regimen)of GSK3923868 on Day 1 and Day 7 Time: Day 1 and 7: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Cmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Tmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7This is an open-label, two-period, single-sequence crossover study including 2 single dose treatments of mometasone furoate 100 μg administered via Twisthaler® and of 75/40 µg indacaterol acetate/mometasone furoate fixed dose combination 75/40 µg (QMF149) administered via Concept 1 device with a washout period between the two treatments. The study will include a screening period of up to 14 days, two single-dose treatments separated by a 4-7 day washout period (4 days is the minimum washout) and a 30-day investigational drug-free follow-up period.
Description: Mometasone furoate plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of mometasone furoate will be determined with Phoenix WinNonlin (Version 6.4 or higher).
Measure: Maximum observed mometasone furoate plasma concentration (Cmax) Time: pre-dose, 0.5, 1, 2, 3 and 6 hours post-dose on Day 1 and Day 6Description: AUC0-6h of mometasone furoate will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUC0-6h calculation.
Measure: Area under the plasma concentration-time curve from time zero to the last sampling time point 6h (AUC0-6h) of mometasone furoate Time: pre-dose, 0.5, 1, 2, 3 and 6 hours post-dose on Day 1 and Day 6Description: Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 6 after inhalation of QMF149.
Measure: Systemic exposure to indacaterol in plasma Time: pre-dose, 0.25 and 1 hour post-dose on Day 6The study is an experimental study with a methodological and pre-test-post-test control group in order to determine the effect of web-designed education developed for asthmatic patients on drug compliance and quality of life.
Description: Medication Compliance Reporting Scale Participants are asked to indicate the frequency of the 5 statements in each of them. The scale is evaluated with a 5-point Likert type such that 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. The total test score is obtained by summing the scores obtained from the items. The scores obtained from the scale range from 5 to 25. An increase in the obtained scores indicates compatibility, and a decrease in scores indicates incompatibility.
Measure: change from baseline in Medication Compliance Reporting Scaleat week 6 Time: baseline and 6 weeksDescription: COPD and Asthma Fatigue Scale (DAS) The scale consists of 12 items, and a Likert type rating (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = very often) is used for its answers. In calculating the scale score, the first 10 questions correspond to never = 1 point, rarely = 2 points, sometimes = 3 points, often = 4 points, very often = 5 points, and in the 11th and 12th questions never = 5 points, rarely = 4 points. , sometimes = 3 points, often = 2 points, very often = 1. The total raw score is determined by adding the scores of each item and the raw scores are converted into a total scale score between 0-100. The higher the score obtained from the scale indicates that the fatigue level of the person is high.
Measure: change from baseline in COPD and Asthma Fatigue Scale (DAS) at week 6 Time: baseline and 6 weeksDescription: Asthma Control Test (AKT); This scale consists of five Likert type and consists of five questions. The maximum score of this test is 25 and the minimum score is 5, while 25 points are "full control", 20-24 points "good control" and a score of less than 19 is considered "uncontrolled"
Measure: change from baseline in Asthma Control Test (AKT) week 6 Time: baseline and 6 weeksDescription: Opinion Form Regarding the Web Based Asthma Education Program This form contains 20 questions prepared to determine the views of asthma patients on the web-based asthma education program.
Measure: evaluating the web-based asthma education program Time: baseline and 6 weeksInterleukin (IL)-5 is the main cytokine responsible for the activation of eosinophils, hence therapeutic strategies have been investigated and developed for clinical use. Biologics targeting IL-5 and its receptor (first mepolizumab and subsequently, reslizumab and benralizumab), have been recently approved and used as add-on therapy for severe eosinophilic asthma resulting in a reduction in the circulating eosinophil count, improvement in lung function and exacerbation reduction in patients with severe asthma. Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice. Aim of this clinical study is to evaluate the efficacy of mepolizumab, a humanized IL-5 antagonist monoclonal antibody in patients with late-onset severe eosinophilic asthma with fixed obstruction and to identify the characteristics of non-responders and super-responders under mepolizumab treatment. This study is considered as non-interventional and every procedure included is happening in a clinical routine for the diagnosis and phenotyping of the asthmatic patients. Hypothesis includes the efficacy of mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction and relation to clinical and inflammatory biomarkers. Patients will be collected from the outpatient clinics of bronchial asthma from each site included (8 in number) which cover the whole population of Greece. Overall, this is a prospective multicenter study including eight Pulmonary Clinics. Five Pulmonary University Clinics, two of National Health System and one Army General Hospital in Thessaloniki. The study will include a screening period of up to 2 weeks to assess eligibility and obtain written informed consent, a mepolizumab treatment period of 52 weeks, once every 4 weeks, including follow up visits every 3 months during treatment. The study population will consist of 45 patients with late-onset severe eosinophilic asthma and fixed obstruction receiving mepolizumab, aged 20 and above.
Description: Mesurement of the change in exacerbation rate in each late-onset severe eosinophilic asthmatic patient with fixed obstruction under mepolizumab treatment for 52 weeks of treatment.
Measure: Change in exacerbation rate Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. FEV1 change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment. FEV1 is the maximal amount of air you can forcefully exhale in one second measured by spirometry.
Measure: Identification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1) Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. Change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment.
Measure: Identification of clinical characteristics of response, change in blood eosinophil levels. Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. Change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment.
Measure: Identification of clinical characteristics of response, change in FENO levels. Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: the Asthma Control Questionnaire (ACQ-5) to assess current asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measure: Identification of clinical characteristics of response, change in Asthma Control Questionnaire Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Asthma Control Test (ACT) to assess current asthma control. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measure: Identification of clinical characteristics of response, change in Asthma Control Test Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: the Asthma Quality of Life Questionnaire (AQLQ+12) to assess quality of life and psychological morbidity. Scores range 1-7, with higher scores indicating better quality of life.
Measure: Identification of clinical characteristics of response, change in Asthma Quality of Life Questionnaire Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Athens Insomnia Scale (AIS) to assess sleeping quality. Total score range form 0 to 24 with higher scores indicating worst sleeping quality. AIS includes 8 questions with scores range from 0 (meaning that the item in question has not been a problem) to 3 (indicating more acute sleep difficulties).
Measure: Identification of clinical characteristics of response, change in Athens Insomnia Scale Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Epworth Sleepiness Scale (ESS) to assess sleeping quality. The total score can range from 0 to 24. Higher scores indicate increased sleepiness.
Measure: Identification of clinical characteristics of response, change in Epworth Sleepiness Scale Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: St. George's Respiratory Questionnaire (SGRQ) to assess sleeping quality. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: Identification of clinical characteristics of response, change in St. George's Respiratory Questionnaire Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: WHO (Five) Well-Being Index (WHO-5) to assess sleeping quality. The total raw score ranges from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measure: Identification of clinical characteristics of response, change in WHO (Five) Well-Being Index Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Fatigue Severity Scale (FSS) to assess sleeping quality. FSS includes a 9-item questionnaire with questions scored on a 7 point scale with 1 meaning strongly disagree and 7 meaning strongly agree. Scores range from 9 to 63. Higher the score indicates greater fatigue severity.
Measure: Identification of clinical characteristics of response, change in Fatigue Severity Scale Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. Any improvement in smooth muscle cell mass will be measured as change from baseline compared to measurement after 1 year of treatment. Increased smooth muscle cell mass indicates airway remodeling and loss of pulmonary function. Smooth muscle cell mass will be determined through the epithelial integrity, reticular basement membrane length and vascularity area.
Measure: Change in smooth muscle cell mass Time: through study completion, 52 weeksDescription: To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood, bronchial washing, sputum, sputum supernatant. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of mepolizumab treatment.
Measure: Change of T-lympocytes percentages Time: through study completion, 52 weeksDescription: To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood, bronchial washing, sputum, sputum supernatant. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of mepolizumab treatment.
Measure: Change of cytokine and protein levels Time: through study completion, 52 weeksNowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment. Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers. Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19. Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients. Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.
Description: ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue in bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff, but it will not be applied in the current study as it will be difficult to be self-reported by the participants. 7-point scale (0=no impairment, 6= maximum impairment for symptoms. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measure: Asthma Control Questionnaire (ACQ) Time: One weekDescription: The MiniAQLQ will be utilized to investigate the HRQoL of the participants. The Mini AQLQ-S has 15 questions that gives an overall summary index and four domains: activity limitation, symptoms, emotional function, and environmental stimuli. The questions all refer to the "last two weeks" and use seven Likert-type response options e.g., seven response options ranging from "all of the time" to "none of the time".
Measure: Mini Asthma Quality of Life Questionnaire Time: two weeksDescription: Perceived Stress Scale is a self-reported measure of the degree to which situations in an individual's life are perceived as stressful. PSS has 14 items can assess the degree to which individuals found their life unpredictable, uncontrollable, and overloaded.
Measure: Perceived Stress Scale Time: monthIn addition to its impact on health, the COVID-19 pandemic has led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Patients with asthma are at risk for adverse health outcomes during the COVID-19 pandemic, and disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes. Our PCORI-funded parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), the investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care. In this supplement to the AFFORD project, the investigators propose a new study to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and feasibility and acceptability of an insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; and 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic The study hypothesis is that participants receiving the intervention will be more likely to have coverage after four months and less likely to report non-adherence to asthma medications, delayed/forgone asthma care, and financial burden than those receiving usual care. Findings will provide evidence about the effectiveness of strategies to obtain coverage and maintain access to affordable asthma care and can inform ongoing and future decision making in response to the COVID-19 pandemic and other public health and economic threats.
Description: Change in coverage status (has any insurance coverage or not)
Measure: Insurance coverage Time: From baseline to follow-up (four months)Description: Change in report of using less asthma medication than prescribed because of cost
Measure: Medication adherence Time: From baseline to follow-up (four months)Description: Change in report of: 1) problems paying medical bills for asthma care, or 2) having to borrow money because of the amount required to pay for asthma care
Measure: Financial burden Time: From baseline to follow-up (four months)Description: Change in report of: 1) using less asthma medication than prescribed because of cost,or 2) delaying or avoiding going to the doctor for asthma because of cost
Measure: Delayed/forgone care due to cost Time: From baseline to follow-up (four months)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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