Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (3)
AZ
- Mayo Clinic · Scottsdale, AZ 85259Karalyn Folmes, Ph.D. · Study contact · 480-301-4298 · folmes.karalyn@mayo.eduGene R Bleecker, MD · Principal investigatorDeborah A Meyers, PhD · Principal investigatorMore trials in Scottsdale
CA
- University of California, San Diego · La Jolla, CA 92093Asthma Research Team · Study contact · 619-431-0995 · asthma@health.ucsd.eduKelan Tantisira, MD · Principal investigatorPraveen Akuthota, MD · Principal investigatorMore trials in La Jolla
CT
- Yale University · New Haven, CT 06520Katherine Spaulding · Study contact · 203-737-5572 · katherine.spaulding@yale.eduGeoffrey L Chupp, MD · Principal investigatorMore trials in New Haven