Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

Study Overview
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Brief Summary
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Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

Official Title
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A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: FP
* Drug: LABA
* Drug: LTRA
* Drug: LAMA
* Drug: Theophylline
* Drug: Oral Corticosteroids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma diagnosed by a respiratory physician greater than or equal to (>/=) 12 months prior to study enrolment Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1 Documented bronchodilator response defined as >/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline Current treatment with a total daily dose of >/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1 Exclusion Criteria: Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1 Ex-smokers with >/=10 pack-year smoking history Prior treatment with bronchial thermoplasty Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study Pregnancy prior to participation or during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inhaled Corticosteroids (ICS) + Controller Medications<br>Participants with severe asthma Global Initiative for Asthma (GINA) step 4/5 as indicated by current treatment with daily ICS consisting of >/=500 mcg FP administered by DPI (or equivalent), and at least one of the following controller medications: LABAs, LTRAs, LAMAs, theophylline or oral corticosteroids. | Drug: FP<br>* ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.<br>Drug: LABA<br>* LABA will be administered as per investigator discretion.<br>Drug: LTRA<br>* LTRA will be administered as per investigator discretion.<br>Drug: LAMA<br>* LAMA will be administered as per investigator discretion.<br>Drug: Theophylline<br>* Theophylline will be administered as per investigator discretion.<br>Drug: Oral Corticosteroids<br>* Oral corticosteroids will be administered as per investigator discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin |  | Baseline up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Asthma Exacerbations |  | Baseline up to Week 52 | 
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points |  | Baseline, Weeks 26, 52 | 
| Time Taken for the Occurrence of First Asthma Exacerbation |  | Baseline up to Week 52 | 
| Time to Treatment Failure |  | Baseline up to Week 52 | 
| Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points |  | Baseline, Weeks 13, 26, 39, 52 | 
| Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points |  | Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) | 
| Change From Baseline in Asthma Control Test (ACT) at Specified Time Points |  | Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) | 
| Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee |  | Baseline up to Week 52 | 
| Serum Periostin Levels During the Study |  | Baseline, Weeks 26, 52 | 
| Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels |  | Baseline, Weeks 26, 52 | 
| Blood Eosinophil Levels During the Study |  | Baseline, Weeks 26, 52 | 
| Serum Immunoglobulin E (IgE) Levels During the Study |  | Baseline, Weeks 26, 52 | 
| Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations |  | Weeks 13, 26, 39, 52 | 
| Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits |  | Weeks 13, 26, 39, 52 | 
| Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits |  | Weeks 13, 26, 39, 52 |