Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well two approved biologic therapies work for patients with moderate to severe asthma. The goal is to understand how each patient responds to these treatments by looking at their genetic information and biological samples. By doing this, researchers hope to find better ways to personalize asthma treatment based on how individual patients respond, which could help improve asthma management for many people.

To be eligible for this study, participants must be between the ages of 18 and 75 and have had stable asthma medications for at least two months. They should also have experienced poorly controlled asthma symptoms and show evidence of asthma through specific tests. Participants will need to commit to following study procedures and lifestyle guidelines throughout the trial. This study is currently recruiting, and anyone considering participation should discuss it with their healthcare provider to learn more about their options and whether they qualify.

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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.