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NCT03878654 · ClinicalTrials.gov registry record · Phase 1
Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma
A Phase 1 study, sponsored by University of Vermont.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03878654: Clinical Trial Phase 1 study, sponsored by University of Vermont.
NCT03878654 is a Phase 1 study that was terminated before completion, run by University of Vermont. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878654, a Phase 1 study, was terminated before completion, sponsored by University of Vermont.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study 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 the airways, often caused by allergies. In order to control this inflammation, most people with asthma are treated with inhaled medications that contain steroids. These medications do a good job of helping most people with asthma feel better. However, these medications are expensive, have side effects, and do not control symptoms in all people with asthma. Recently basic science research colleagues have shown that inflammation due to allergies can be reduced in experimental animals by a naturally occurring bile acid. Bile acids are chemicals made in the liver that are involved in maintaining healthy digestion of fat. Since bile acids are made by our bodies, they have become popular as over the counter supplements that are thought to be important in promoting a healthy liver and metabolism. Interestingly, other research has shown that bile acids may help patients with neurological disease and diabetes. Given all of this information, the investigators propose that a specific bile acid called tauroursodeoxycholic acid (TUDCA) may be helpful in patients with asthma. Before studying this in a clinical trial, the current study is designed to demonstrate that people with asthma can take TUDCA safely and that it doesn't hurt their asthma. The study will involve inviting 12 patients with mild asthma to take TUDCA daily for 12 weeks. During this time the investigators will closely monitor them for any side effects and check their blood and breathing capacity for any signs of detrimental effects. In addition, the investigators will collect cells that line the nose, which are thought to be similar to cells in the airways of the lungs, to see if TUDCA is having any beneficial effects on inflammation. In order to ensure the use of high quality TUDCA, which may or may not be true of
Primary Outcome
Liver toxicity by AST
Interventions
- DRUG Tauroursodeoxycholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2019-09-11 |
| Phase | Phase 1 |
Why NCT03878654 stopped before completion
NCT03878654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Tauroursodeoxycholic Acid is the first listed.
NCT03878654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03878654 about?
NCT03878654 is a clinical study titled "Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma". 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 the airways, often caused by allergies. In order to control this inflammation, most people with ast...
What is the current status of trial NCT03878654?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-01-10. Estimated completion is 2019-09-11.
What interventions are being tested in trial NCT03878654?
The interventions under investigation include: Tauroursodeoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT03878654?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03878654's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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