The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

Phase 1

Completed

• Conditions: Chronic Asthma

• Registration Number: NCT00739297
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-21
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2010-01-14
• Results First Submitted QC: 2010-03-25
• Results First Posted: 2010-04-09
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change From Baseline in FEV1 Over 4 Hours	0 (=baseline) to 4 hours after treatment with montelukast	FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration	4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast	FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.