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NCT03060772 · ClinicalTrials.gov registry record · Phase 2
A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study)
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT03060772: Clinical Trial Phase 2 study, sponsored by Emory University.
NCT03060772 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060772, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study is a single center, open-label, randomized clinical trial to determine the effect of pioglitazone (PIO) treatment on alveolar macrophage immune function, redox stress, and NADPH oxidase expression in outpatient alcoholic subjects. The researchers will recruit a cohort of otherwise healthy patients with an alcoholic use disorder from the Substance Abuse Treatment Program at the Atlanta Veterans Affairs (VA) Medical Center and randomize them to receive the usual treatment for two to four weeks or to the usual treatment plus PIO treatment for two to four weeks. There will also be a healthy control group (matched on age, gender, and smoking status) that will receive no treatment. To measure the effect of pioglitazone, participants will undergo a bronchoscopy before taking the study drug and then again 2-4 weeks later to look for changes. The bronchoscopy will allow researchers to obtain fluid from the lungs to see how well their immune cells respond to bacteria by determining phagocytic capacity.
Primary Outcome
The change in phagocytic index will be determined between the alcohol use disorder study arms to examine the effect of PIO treatment. Phagocytic index of the alveolar macrophage is the rate at which particles are cleared from a culture. The phagocytic index is a well-established marker of immune function and its improvement with pioglitazone (PIO) treatment would indicate reversal of the alcoholic lung phenotype. The phagocytic index will be measured in bronchoalveolar lavage (BAL) fluids.
Interventions
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2020-01-28 |
| Phase | Phase 2 |
Why NCT03060772 stopped before completion
NCT03060772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Pioglitazone is the first listed.
NCT03060772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03060772 about?
NCT03060772 is a clinical study titled "A Study of Pleiotropic Pioglitazone Effects on the Alcoholic Lung (APPEAL Study)". This study is a single center, open-label, randomized clinical trial to determine the effect of pioglitazone (PIO) treatment on alveolar macrophage immune function, redox stress, and NADPH oxidase expression in outpatient alcoholic subjects. The researchers will recruit a cohort of otherwise healthy...
What is the current status of trial NCT03060772?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2018-01-03. Estimated completion is 2020-01-28.
What interventions are being tested in trial NCT03060772?
The interventions under investigation include: Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT03060772?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03060772's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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