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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: Completed Phase 3 study, sponsored by Kaiser Permanente.
NCT00162864 is a Phase 3 study that has completed, run by Kaiser Permanente. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00162864 record still lists
NCT00162864 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which montelukast sodium is the first listed.
NCT00162864 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00162864's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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