EPIPHANY study for people with moderate to severe asthma
- Study HIC#:2000032380
- Last Updated:05/03/2024
The EPIPHANY study aims to identify the best treatments for people with moderate to severe asthma by using a new approach where each participant will be treated with guideline-based standard of care throughout the study and then evaluated by clinical responses and changes in expression of genes after treatment with FDA approved medications: systemic corticosteroid (triamcinolone acetonide), and two biologics for moderate to severe asthma an anti-IL-5 receptor (benralizumab) and anti-IL-4 receptor (dupilumab). Participation will include a screening and run-in period and if you qualify, 10 additional clinical visits. Study procedures include questionnaires, measurements, maintenance of a peak flow diary, blood draws, sputum (a mixture of saliva and mucus coughed up from the respiratory tract) collection, spirometry, fractional exhaled nitric oxide (FeNO) tests, and nasal brushings.
Contact Us
For more information about this study, including how to volunteer, contact:
Katie Spaulding
- Phone Number: 1-203-737-5572
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
The EPIPHANY study aims to identify the best treatments for people with moderate to severe asthma by using a new approach where each participant will be treated with guideline-based standard of care throughout the study and then evaluated by clinical responses and changes in expression of genes after treatment with FDA approved medications: systemic corticosteroid (triamcinolone acetonide), and two biologics for moderate to severe asthma an anti-IL-5 receptor (benralizumab) and anti-IL-4 receptor (dupilumab). Participation will include a screening and run-in period and if you qualify, 10 additional clinical visits. Study procedures include questionnaires, measurements, maintenance of a peak flow diary, blood draws, sputum (a mixture of saliva and mucus coughed up from the respiratory tract) collection, spirometry, fractional exhaled nitric oxide (FeNO) tests, and nasal brushings.
Eligibility Criteria
Eligibility:
- Male or female ages 18-65,
- Stable asthma medications, no changes in 2 months prior to screening,
- Use of high dose ICS and an additional controller medication,
- Baseline of poor or uncontrolled asthma,
- Bronchodilator reversibility/positive methacholine,
- Compliance to asthma medication and adherence to study protocol >80%.