Montelukast Asthmatic Smoker Study - Full Text View

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: fluticasone Drug: Comparator: Placebo (unspecified)	Phase III

MedlinePlus related topics:

Asthma Smoking

ChemIDplus related topics:

Fluticasone propionate Fluticasone Montelukast Montelukast sodium

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

Evaluate the treatment effect on asthma-control days at 6 months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1200
Study Start Date:	May 2006
Estimated Primary Completion Date:	January 2009 (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 (unspecified) fluticasone propionate 250 mg Pbo tablet bid twice daily, 6 month treatment period.
2: Active Comparator Arm 2: Active Comparator	Drug: Comparator: fluticasone fluticasone propionate 250 mg bid twice daily, 6 month treatment period. Drug: Comparator: Placebo (unspecified) montelukast 10 mg Pbo tablet once daily, 6 month treatment period.
3: Placebo Comparator Arm 3: Placebo	Drug: Comparator: Placebo (unspecified) montelukast 10 mg Pbo tablet once daily, 6 month treatment period. Drug: Comparator: Placebo (unspecified) fluticasone propionate 250 mg Pbo tablet bid twice 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

Show 19 Study Locations

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More 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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_108, MK0476-332
First Received:	January 31, 2006
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00284856
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Study placed in the following topic categories:

Montelukast

Smoking

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Asthma

Leukotriene Antagonists

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Bronchial Diseases

Immune System Diseases

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Anti-Allergic Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 03, 2008

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