Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium

• Registration Number: NCT00284856
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Study Start: 2006-05
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-06
• Results First Submitted QC: 2011-04-06
• Results First Posted: 2011-05-03
• Status Verified: 2022-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1640

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast sodium	Arm 1: Montelukast

Primary Outcome Measures

Name	Time	Method
Percentage of Asthma-control Days Over the 6-month Treatment Period	6 months	An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of \> than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period	Baseline and 6 months	PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.
Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period	Baseline and 6 months	4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score \& the mean baseline daytime symptom score.