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

NCT00284856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1640

Last updated 2024-05-10

Study results available
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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.

Conditions

Interventions

DRUG

montelukast sodium

montelukast 10 mg tablet once daily, 6 month treatment period

DRUG

Comparator: Placebo

fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period

DRUG

Comparator: fluticasone

fluticasone propionate 250 mcg twice daily, 6 month treatment period

DRUG

Comparator: Placebo

montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-04-30
Completion
2010-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00284856 on ClinicalTrials.gov