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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
483
Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin
Time frame: Baseline up to Week 52
Percentage of Participants With Asthma Exacerbations
Time frame: Baseline up to Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points
Time frame: Baseline, Weeks 26, 52
Time Taken for the Occurrence of First Asthma Exacerbation
Time frame: Baseline up to Week 52
Time to Treatment Failure
Time frame: Baseline up to Week 52
Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points
Time frame: Baseline, Weeks 13, 26, 39, 52
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
LAMA will be administered as per investigator discretion.
Theophylline will be administered as per investigator discretion.
Oral corticosteroids will be administered as per investigator discretion.
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
...and 90 more locations
Serum Periostin Levels During the Study
Time frame: Baseline, Weeks 26, 52
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels
Time frame: Baseline, Weeks 26, 52
Blood Eosinophil Levels During the Study
Time frame: Baseline, Weeks 26, 52
Serum Immunoglobulin E (IgE) Levels During the Study
Time frame: Baseline, Weeks 26, 52
Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations
Time frame: Weeks 13, 26, 39, 52
Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits
Time frame: Weeks 13, 26, 39, 52
Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits
Time frame: Weeks 13, 26, 39, 52