Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
Eligible age
18–75 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: University of California, San Diego
You may qualify if…
- ✓ Stated willingness to comply with all study procedures and availability for the duration of the study.
- ✓ Stable asthma medications: No change in asthma medications for the past 2 months:
- ✓ 1. Use of medium or high dose inhaled corticosteroids (ICS) AND
- ✓ 2. Use of an additional asthma controller medication.
- ✓ Baseline poor or uncontrolled asthma.
- ✓ Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence).
- ✓ Agreement to adhere to Lifestyle Considerations throughout study duration.
You may not qualify if…
- ✕ 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.
- ✕ Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.
- ✕ Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
- ✕ Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy.
- ✕ Underwent a bronchial thermoplasty within the last two years.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06385236 · last updated 2024-08-19