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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. 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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00656058
The ClinicalTrials.gov registry entry for NCT00656058 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Singulair (Montelukast Sodium) is the first listed.
NCT00656058 reports 0 study locations.
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.
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