Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers
Phase 4
Completed
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT02537691
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inhaled Corticosteroids (ICS) + Controller Medications FP 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. Inhaled Corticosteroids (ICS) + Controller Medications LABA 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. Inhaled Corticosteroids (ICS) + Controller Medications LTRA 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. Inhaled Corticosteroids (ICS) + Controller Medications Oral Corticosteroids 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. Inhaled Corticosteroids (ICS) + Controller Medications LAMA 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. Inhaled Corticosteroids (ICS) + Controller Medications Theophylline 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Percentage of Participants With Asthma Exacerbations Baseline up to Week 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
Trial Locations
- Locations (100)
Clinical Research Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
Southern California Research Center
🇺🇸Mission Viejo, California, United States
Capital Allergy Resp Dis Ctr
🇺🇸Sacramento, California, United States
Allergy Assoc Medical Group
🇺🇸San Diego, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Waterbury Pulmonary Associates
🇺🇸Waterbury, Connecticut, United States
AAADRS; Clinical Research Center
🇺🇸Coral Gables, Florida, United States
Volunteer Medical Research
🇺🇸Port Charlotte, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Georgia Pollens Clinical Research Centers
🇺🇸Albany, Georgia, United States
Scroll for more (90 remaining)Clinical Research Center of Alabama, LLC🇺🇸Birmingham, Alabama, United States