Phase 3 N=1,019 Randomized Double-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00284856 ↗

Enrolled (actual)

1,019

Serious AEs

2.9%

Results posted

May 2011

Primary outcome: Primary: Percentage of Asthma-control Days Over the 6-month Treatment Period — 50.70; 53.30; 43.84 Percentage of days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: montelukast sodium (Drug); Comparator: Placebo (Drug); Comparator: fluticasone (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Apr 2010

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.