Actively Recruiting
Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
Led by University of California, San Diego · Updated on 2024-08-19
120
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to follow all study procedures and be available for the entire study duration
- Stable asthma medications with no changes for the past 2 months, including medium or high dose inhaled corticosteroids and an additional asthma controller
- Diagnosis of poor or uncontrolled asthma at baseline
- Evidence of asthma by bronchodilator reversibility or methacholine responsiveness
- Agreement to follow lifestyle considerations during the study
You will not qualify if you...
- Currently participating in another interventional trial
- Use of asthma biologic treatment within 3 months before screening
- Participation in clinical trials with study medication within the past 60 days or 5 half-lives
- Diagnosis of other chronic lung diseases such as cystic fibrosis, COPD, chronic bronchitis, emphysema, or severe chest deformities
- Use of immune-modulating therapies for non-asthma diseases, including biologics approved for asthma
- Use of methotrexate, mycophenolate, or azathioprine
- Receiving aero allergen immunotherapy without at least 3 months of maintenance therapy
- Bronchial thermoplasty within the last 2 years
- Born before 30 weeks of gestation
- Uncontrolled high blood pressure (systolic >160 mm/Hg or diastolic >100 mm/Hg)
- History of malignancy except non-melanoma skin cancer within 5 years
- History of smoking: 5 or more pack-years if under 45 years old, or 10 or more pack-years if 45 or older
- Active inhalant drug use more than once per month in the past year
- Substance abuse within the past year
- Pregnancy, lactation, or unwillingness to use medically acceptable birth control or abstinence during the study
- Need for daily systemic corticosteroids at screening
- Recent respiratory infection within 1 month
- Intubation for asthma in the last 12 months
- Significant abnormal clinical findings that may risk participation or affect study results
- Body mass index over 38
- Allergy to any drugs, biologics, or chemicals used in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
C
Clinical Trial Operations and Data Management Specialist UA-DCC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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