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A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke Cigarettes - Montelukast Asthmatic Smoker Study

A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke Cigarettes - Montelukast Asthmatic Smoker Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005984-27-FI
Enrollment
1200
Registered
2006-02-16
Start date
2006-03-23
Completion date
Unknown
Last updated
2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma MedDRA version: 8.1 Level: LLT Classification code 10003553

Interventions

Trade Name: SINGULAIR Product Name: montelukast sodium Product Code: N/A Pharmaceutical Form: Tablet INN or Proposed INN: montelukast sodium CAS Number: 158966-92-8 Other descriptive name: MK-0476 Co

Sponsors

Suomen MSD Oy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient is a male or female 18-55 years inclusive. Consistent clinical history of chronic asthma. Cigarette smokers with a smoking history of 30 pack year history or less. Patient has a defined range of FEV1, evidence of reversibility airway obstruction and reached a predetermined level of baseline beta-agonist use during the run in period. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient has diagnosis of Chronic Obstructive Pulmonary Disease and/or emphysema.

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the treatment effect of montelukast 10 mg vs. placebo in asthmatic patients who smoke cigarettes, over a 6 month treatment period on the percentage of asthma-control days. ;Secondary Objective: In asthmatic patients who smoke cigarettes after 6 months of treatment: To compare the treatment effect of montelukast 10mg vs. fluticasone propionate 250 mcg bid. To compare the treatment effect of fluticasone propionate 250 mcg bid vs placebo. Determine the safety and tolerability of montelukast 10mg and fluticasone propionate 250 mcg bid.;Primary end point(s): Asthma Control Day: any day with no unscheduled visit for asthma care to an office, emergent or hospital setting, no use of more than 2 puffs of beta agonist, no use of other asthma rescue medication and no nocturnal awakening.—

Countries

Austria, Belgium, Estonia, Finland, Greece, Hungary, Lithuania, Portugal, Slovenia, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026