Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED) - Full Text View

Purpose

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: Comparator: Placebo Drug: Comparator: fluticasone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Smoking

Drug Information available for: Fluticasone propionate Fluticasone Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of Asthma-control Days Over the 6-month Treatment Period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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:

Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
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.
Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
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.

Enrollment:	1640
Study Start Date:	May 2006
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Arm 1: Montelukast	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
Active Comparator: 2 Arm 2: Fluticasone	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
Placebo Comparator: 3 Arm 3: Placebo	Drug: Comparator: Placebo fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period Drug: Comparator: Placebo montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284856

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00284856 History of Changes
Other Study ID Numbers:	MK-0476-332, 2005_108
Study First Received:	January 31, 2006
Results First Received:	April 6, 2011
Last Updated:	April 6, 2011
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Montelukast
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013