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NCT01307462 · ClinicalTrials.gov registry record · Phase 2
Targeted Therapy of Bronchiolitis Obliterans Syndrome
A Phase 2 study of Bronchiolitis Obliterans, sponsored by Stephanie Lee.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 11
- Study locations
NCT01307462: Completed Phase 2 study of Bronchiolitis Obliterans, sponsored by Stephanie Lee.
NCT01307462 is a Phase 2 study of Bronchiolitis Obliterans that has completed, run by Stephanie Lee. The registered enrollment target is 36 participants, below the 405-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (91% lower). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307462, a Phase 2 study of Bronchiolitis Obliterans, has completed, sponsored by Stephanie Lee.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase II trial studies how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans
Primary Outcome
Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by \>= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement.
Conditions Studied
Interventions
- DRUG azithromycin
- DRUG fluticasone propionate
- DRUG montelukast sodium
Study Locations (11)
Arizona
- Mayo Clinic - Scottsdale - Scottsdale
California
- Stanford University - Stanford
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Maryland
- National Cancer Institute Experimental Transplantation & Immunology Branch - Bethesda
Massachusetts
- Dana-Farber Cancer Institute - Boston
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
Missouri
- Siteman Cancer Center at Washington University - St Louis
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01307462 record still lists
NCT01307462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 405-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Bronchiolitis Obliterans appearing as the primary indexed condition, and to 3 interventions - of which azithromycin is the first listed.
NCT01307462 lists 11 locations in 11 states (Arizona, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01307462 about?
NCT01307462 is a clinical study titled "Targeted Therapy of Bronchiolitis Obliterans Syndrome". This phase II trial studies how well giving fluticasone propionate, azithromycin, and montelukast sodium (FAM) together works in treating patients with bronchiolitis obliterans who previously underwent stem cell transplant. FAM may be an effective treatment for bronchiolitis obliterans
What is the current status of trial NCT01307462?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2011-06. Estimated completion is 2015-12.
What conditions does trial NCT01307462 study?
This clinical trial studies the following conditions: Bronchiolitis Obliterans.
What interventions are being tested in trial NCT01307462?
The interventions under investigation include: azithromycin (DRUG), fluticasone propionate (DRUG), montelukast sodium (DRUG).
Who is sponsoring clinical trial NCT01307462?
This trial is sponsored by Stephanie Lee, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01307462 being conducted?
This trial has 11 study locations across Arizona, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bronchiolitis Obliterans
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01307462's enrollment target sits among peer trials
36 7th of 9 higher than 3 of 9 other Bronchiolitis Obliterans trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchiolitis Obliterans 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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