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NCT00656058 · ClinicalTrials.gov registry record · Phase 2
Montelukast to Treat Bronchiolitis Obliterans
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00656058: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00656058 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656058, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Background: Bronchiolitis obliterans is a form of chronic graft-versus-host disease (GVHD) that sometimes develops after stem cell transplantation (SCT) or bone marrow transplantation (BMT). In bronchiolitis obliterans, immune cells that normally fight infections attack the lungs of the transplant recipient, causing destruction of lung tissue and fibrosis (scarring). When fibrosis develops, the lungs cannot work properly. Montelukast (Singulair) is a drug that has been used for many years to treat asthma. Its use as a treatment for bronchiolitis obliterans is experimental. Objectives: To see if montelukast improves or stabilizes lung function in patients who develop bronchiolitis obliterans after BMT or SCT. To assess the safety of montelukast in patients with bronchiolitis obliterans after BMT or SCT To see if montelukast affects the cells that damage the lungs. To see if montelukast improves other forms of chronic GVHD, quality of life, and overall survival in patients with bronchiolitis obliterans after BMT or SCT. Eligibility: Patients 6 years of age and older with bronchiolitis obliterans following stem cell transplantation. Design: Patients take one montelukast tablet daily for 6 months and undergo the following procedures during this period: * Lung function tests. The patient breathes into a machine that measures the amount of air that goes into and out of the lungs. This test is done once a month for 3 months, then at 6 months, 12 months and 24 months. * Medical history and physical examination at the study site about every 3 months for the first year of the study and then at 12 months and 24 months. Patients also have physical examinations monthly for the first 6 months at their primary doctors office. Tests may include blood and urine tests, chest computed tomography (CT) scans, echocardiogram (heart ultrasound), 2- and 6-minute walk tests, and quality-of-life questionnaires. * Bronchoalveolar lavage in patients 18 years of age and older. The
Primary Outcome
Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as \>15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as \<15% change in the absolute FEV-1.
Interventions
- DRUG Singulair (Montelukast Sodium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-06-17 |
| Est. Completion | 2018-02-22 |
| Phase | Phase 2 |
What the finished NCT00656058 record still lists
NCT00656058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Singulair (Montelukast Sodium) is the first listed.
NCT00656058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656058 about?
NCT00656058 is a clinical study titled "Montelukast to Treat Bronchiolitis Obliterans". Background: Bronchiolitis obliterans is a form of chronic graft-versus-host disease (GVHD) that sometimes develops after stem cell transplantation (SCT) or bone marrow transplantation (BMT). In bronchiolitis obliterans, immune cells that normally fight infections attack the lungs of the transplant...
What is the current status of trial NCT00656058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2008-06-17. Estimated completion is 2018-02-22.
What interventions are being tested in trial NCT00656058?
The interventions under investigation include: Singulair (Montelukast Sodium) (DRUG).
Who is sponsoring clinical trial NCT00656058?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656058's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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