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COMPLETED Phase 2

Targeted Therapy of Bronchiolitis Obliterans Syndrome

NCT01307462 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 36 participants
Start Date 2011-06
Est. Completion 2015-12
Phase Phase 2

Sponsor

Stephanie Lee

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01307462

The ClinicalTrials.gov registry entry for NCT01307462 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stephanie Lee, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01307462 reports 11 study locations spanning 11 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01307462?

The interventions under investigation include: azithromycin (DRUG), fluticasone propionate (DRUG), montelukast sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01307462?

This trial is sponsored by Stephanie Lee, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial