Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, San Diego

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

120 Participants
are divided into 2 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