RecruitingPhase 4NCT06385236

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Sponsor

University of California, San Diego

Enrollment

120 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Moderate to Severe Asthma

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using genetic testing (pharmacogenomics) to understand why some people with asthma respond differently to medications, with the goal of personalizing asthma treatment for better control. **You may be eligible if...** - You have asthma that is poorly controlled despite using medium-to-high doses of inhaled steroids plus at least one other asthma controller medication - Your asthma medications have been stable for the past 2 months - You are willing to follow the study plan throughout **You may NOT be eligible if...** - You are currently on a biologic treatment for asthma (like dupilumab or mepolizumab) or have been in the past 3 months - You have COPD, cystic fibrosis, or other significant lung diseases - You smoke heavily or have a significant smoking history - You are pregnant or breastfeeding - Your BMI is above 38 - You have had a respiratory infection within the last month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDupilumab

Dupilumab, an interleukin-4 receptor treatment, will be administered through a subcutaneous injection, the initial dose of 600 mg will be administered at two different injection sites (300 mg per injection), followed by a single dose of 300 mg administered every other week (Q2W). Participants may self-administer injection after proper training.

BIOLOGICALBenralizumab

Benralizumab, an interleukin-5 receptor treatment, will be administered through a subcutaneous injection every 4 weeks (Q4W). Participants may self-administer injection after proper training.