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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
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 |