Status:
TERMINATED
Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma
Lead Sponsor:
University of Vermont
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Asthma is a chronic lung disease that affects millions of people worldwide, including both children and adults. The cause of asthma is not known, but asthma is strongly associated with inflammation of...
Detailed Description
Study Design: This study will be a Phase 1, pre-post intervention trial in patients with asthma who will be treated with TUDCA 1750 mg per day for 12 weeks. The investigators have obtained TUDCA from ...
Eligibility Criteria
Inclusion
- Men and women, aged 18 and older, with a physician diagnosis of asthma
- Current non-smoker with \< 10 pack-years smoking history and no smoking within the last year
- Stable asthma control over the last 3 months as defined by Asthma Control Test (ACT) ≥ 20 (40)
- Stable asthma medication regimen over the last 3 months
- FEV1 ≥ 70% predicted
Exclusion
- Current smoking or ≥10 pack-years of smoking or any smoking within the last year
- Poor asthma control as defined by ACT\< 20
- Exacerbation of disease within previous 4 weeks
- Recent upper respiratory infection within last 4 weeks
- Acute or chronic rhinosinusitis
- Use of chronic nasal corticosteroids, or any use of nasal corticosteroids during the study
- Concomitant heart, lung or GI disease (liver, peptic ulcer) that would potentially jeopardize the safety of the participant or interfere with interpretation of the results
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03878654
Start Date
January 10 2019
End Date
September 11 2019
Last Update
September 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vermont Lung Center
Colchester, Vermont, United States, 05446