Phase 1
Completed N=136
The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)
Chronic Asthma
Source: ClinicalTrials.gov NCT00739297 ↗
Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline in FEV1 Over 4 Hours — 0.03; 0.07; 0.13; 0.10 L (Liter)
Summary
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in FEV1 Over 4 Hours |
0.03; 0.07; 0.13; 0.10; 0.09; 0.12 | — |
| SECONDARY Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration |
0.34; 0.15 | — |
Eligibility Criteria
Inclusion Criteria
- A person is 15 to 65 years of age. A person has had chronic asthma for at least one year
Exclusion Criteria
- A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
- A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)
Data sourced from ClinicalTrials.gov (NCT00739297). 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.