A Study of MK0476 to Prevent Exercise-Induced Bronchospasm - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00245570

Purpose

To determine the effect of an approved medication (MK0476) being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

Condition	Intervention	Phase
Asthma, Exercise-Induced	Drug: MK0476, Montelukast Sodium / Duration of treatment approximately 6 months Drug: Comparator: Salmeterol / Duration of treatment approximately 6 months	Phase III

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Montelukast sodium Montelukast Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction

Further study details as provided by Merck:

Primary Outcome Measures:

Maximum percent-fall (post-exercise change from pre-exercise baseline) in FEV1 after exercise challenge performed at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the curve for percent-fall from pre-exercise FEV1 over time, Time to recovery of FEV1 to within 5% or pre-exercise baseline, and Use of inhaled short-acting B-agonist (as "rescue" medication) following challenge. [ Time Frame: following challenge ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	December 2005
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	15 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Physician-diagnosed exercise-induced bronchospasm

Exclusion Criteria:

Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245570

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Philip G, Pearlman DS, Villarán C, Legrand C, Loeys T, Langdon RB, Reiss TF. Single-dose montelukast or salmeterol as protection against exercise-induced bronchoconstriction. Chest. 2007 Sep;132(3):875-83. Epub 2007 Jun 15.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_043, MK0476-316
Study First Received:	October 26, 2005
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00245570
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Montelukast
Asthma, Exercise-Induced
Hypersensitivity
Salmeterol
Bronchial Spasm

Respiratory Tract Diseases
Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009