Phase 3
Completed N=1,019
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
Source: ClinicalTrials.gov NCT00284856 ↗Enrolled (actual)
1,019
Serious AEs
2.9%
Results posted
May 2011
Primary outcomePrimary: Percentage of Asthma-control Days Over the 6-month Treatment Period — 50.70; 53.30; 43.84 Percentage of days
Summary
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Asthma-control Days Over the 6-month Treatment Period |
50.70; 53.30; 43.84 | — |
| SECONDARY Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period |
1.82; 1.78; 1.90; -0.41; -0.44; -0.27 | — |
| SECONDARY Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period |
363.75; 354.28; 347.98; 12.84; 19.31; 8.27 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day
Exclusion Criteria
- Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
Data sourced from ClinicalTrials.gov (NCT00284856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.