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Montelukast Asthmatic Smoker Study
This study is currently recruiting participants.
Verified by Merck, July 2009
First Received: January 31, 2006   Last Updated: July 1, 2009   History of Changes
Sponsored by: 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:


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:
  • AM Peak Expiratory Flow Rate (PEFR) and daytime symptom score over the 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: May 2010
Estimated Primary Completion Date: April 2010 (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

  Show 17 Study Locations
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
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: July 1, 2009
ClinicalTrials.gov Identifier: NCT00284856     History of Changes
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Study placed in the following topic categories:
Anti-Inflammatory Agents
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Hormones
Leukotriene Antagonists
Montelukast
Smoking
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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 July 02, 2009