Using genetics to improve asthma treatment

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

This study is testing how well two asthma treatments work for people with moderate to severe asthma by looking at their genetic information to see who might benefit the most.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of California, San Diego (other)
• Drugs / interventions: immunotherapy, methotrexate, benralizumab, dupilumab
• Locations: 3 sites (Scottsdale, Arizona and 2 other locations)
• Trial ID: NCT06385236 on ClinicalTrials.gov

What this trial studies

This study evaluates how well patients with moderate to severe asthma respond to two approved biologic therapies, dupilumab and benralizumab, by analyzing genomic and biological data from their biosamples. Participants will undergo a series of assessments to characterize their responses to these treatments, which will help identify mechanisms underlying severe asthma. The study aims to enhance personalized treatment strategies by providing insights into which patients are likely to benefit from specific therapies. It follows standard care procedures and includes longitudinal assessments to track individual responses over time.

Who should consider this trial

Good fit: Ideal candidates are adults with moderate to severe asthma who have stable medication regimens and meet specific inclusion criteria.

Not a fit: Patients currently on asthma biologics or participating in other interventional trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective asthma treatments for patients.

How similar studies have performed: Other studies have shown promise in using pharmacogenomics for personalized medicine, but this approach is innovative in its specific application to asthma treatment.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Born before 30 weeks of gestation.
* Uncontrolled hypertension, defined as systolic blood pressure \> 160 mm/Hg or diastolic blood pressure \> 100 mm/Hg.
* History of malignancy except non-melanoma skin cancer within the last five years.
* History of smoking:

  1. If \<45 years old: Smoked for ≥5 pack-years\*
  2. If ≥45 years old: Smoked ≥ 10 pack years.
* Active use of any inhalant \>1 time per month in the past year.
* Substance abuse within the last year.
* Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation.
* Requirement for daily systemic corticosteroids at the time of screening.
* Respiratory infection within 1 month of screening.
* Intubation for asthma in the last 12 months.
* Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
* BMI \> 38.
* Allergic to any of the drugs, biologics or chemicals used in this study.

Where this trial is running

Scottsdale, Arizona and 2 other locations

• Mayo Clinic — Scottsdale, Arizona, United States (RECRUITING)
• University of California, San Diego — La Jolla, California, United States (RECRUITING)
• Yale University — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Kelan Tantisira, MD — University of California, San Diego
• Study coordinator: Clinical Trial Operations and Data Management Specialist UA-DCC

Conditions: Moderate to Severe Asthma, Asthma