About this trial
In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.
By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment.
Eligibility criteria
Qualifiers
Stated willingness to comply with all study procedures and availability for the duration of the study.
Use of medium or high dose inhaled corticosteroids (ICS) AND
Use of an additional asthma controller medication.
Baseline poor or uncontrolled asthma.
Disqualifiers
Current participation in an interventional trial (e.g. drugs, diets, etc.).
Currently on an asthma biologic or having been on biologic within 3 months of screening.
Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).
Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
Trial design
Treatments tested in this trial
- Dupilumab
- Benralizumab
Treatment groups
Sponsors and collaborators
University of California, San Diego
Lead sponsor
Mayo Clinic
Collaborator
Yale University
Collaborator
University of Arizona
Collaborator
Harvard University
Collaborator
Brigham and Women's Hospital
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator