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NCT00162864 · ClinicalTrials.gov registry record · Phase 3
A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT00162864 is a Phase 3 study that has completed, run by Kaiser Permanente. The registered enrollment target is 200 participants.
The verdict
NCT00162864, a Phase 3 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow measurements, and health care utilization were also assessed as secondary outcomes. Participants were recruited from the Kaiser Permanente Northwest member population. One hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or placebo, and were followed for a six-week period. No differences in lung function measures, health-related quality of life, health care utilization, and asthma symptom scores were observed; however, the montelukast group had slightly improved asthma control scores compared to the placebo group.
Interventions
- DRUG montelukast sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 1999-12 |
| Est. Completion | 2002-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00162864
The ClinicalTrials.gov registry entry for NCT00162864 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which montelukast sodium is the first listed.
NCT00162864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00162864 about?
NCT00162864 is a clinical study titled "A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease". This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms scores. Nocturnal symptoms,...
What is the current status of trial NCT00162864?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 1999-12. Estimated completion is 2002-04.
What interventions are being tested in trial NCT00162864?
The interventions under investigation include: montelukast sodium (DRUG).
Who is sponsoring clinical trial NCT00162864?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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