Montelukast Asthmatic Smoker Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00284856

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: montelukast sodium Drug: Comparator: Placebo Drug: Comparator: fluticasone Drug: Comparator: Placebo.	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Secondary Outcome Measures:

Average change from baseline in mean daytime symptom score over a 6-month treatment period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in average AM PEFR (peak expiratory flow rate) over a 6-month treatment period [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	May 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

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

Patients with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

Exclusion Criteria:

Patient can not 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

PhRMA Clinical Study Results Database - web-based repository for clinical study results 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_108, MK0476-332
Study First Received:	January 31, 2006
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00284856 History of Changes
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Montelukast
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009