Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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:

‣ Use of medium or high dose inhaled corticosteroids (ICS) AND

⁃ 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.

Locations
United States
Arizona
Mayo Clinic
RECRUITING
Scottsdale
California
University of California, San Diego
RECRUITING
La Jolla
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Clinical Trial Operations and Data Management Specialist UA-DCC
bio5-epiphanydcc@arizona.edu
520-626-9552
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Dupilumab
600 mg once subcutaneously (given as two 300 mg injections), followed by 300 mg subcutaneously every other week.
Active_comparator: Benralizumab
30 mg subcutaneously every 4 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, Yale University, Brigham and Women's Hospital, University of Arizona, National Heart, Lung, and Blood Institute (NHLBI), Harvard University
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov