Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction - Full Text View

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

Purpose

To determine the effect of an approved medication 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: Comparator: Montelukast Drug: Comparator: Salmeterol Drug: Comparator: Placebo (montelukast) Drug: Comparator: Placebo (salmeterol)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Salmeterol Salmeterol xinafoate Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB) [ Time Frame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose ] [ Designated as safety issue: No ]
In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.

Secondary Outcome Measures:

Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose [ Time Frame: 0-90 minutes after the exercise challenge performed at 2 hours postdose ] [ Designated as safety issue: No ]
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose [ Time Frame: 0-90 minutes after the exercise challenge performed at 8.5 hours postdose ] [ Designated as safety issue: No ]
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose [ Time Frame: 0-90 minutes after the exercise challenge performed at 24 hours postdose ] [ Designated as safety issue: No ]
Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB [ Time Frame: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose ] [ Designated as safety issue: No ]
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB [ Time Frame: 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose ] [ Designated as safety issue: No ]
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose [ Time Frame: 0-60 minutes after the exercise challenge at 2 hours postdose ] [ Designated as safety issue: No ]
The measure included only the area below the pre-exercise baseline
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose [ Time Frame: 0-60 minutes after the exercise challenge at 8.5 hours postdose ] [ Designated as safety issue: No ]
The measure included only the area below the pre-exercise baseline
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose [ Time Frame: 0-60 minutes after the exercise challenge at 24 hours postdose ] [ Designated as safety issue: No ]
The measure included only the area below the pre-exercise baseline
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose [ Time Frame: Exercise challenge at 2 hours postdose ] [ Designated as safety issue: No ]
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose [ Time Frame: Exercise challenge at 8.5 hours postdose ] [ Designated as safety issue: No ]
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose [ Time Frame: Exercise challenge at 24 hours postdose ] [ Designated as safety issue: No ]
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.

Enrollment:	47
Study Start Date:	December 2005
Study Completion Date:	August 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Montelukast - Salmeterol - Placebo	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Experimental: 2 Montelukast - Placebo - Salmeterol	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Experimental: 3 Salmeterol - Montelukast - Placebo	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Experimental: 4 Salmeterol - Placebo - Montelukast	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Experimental: 5 Placebo - Montelukast - Salmeterol	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Experimental: 6 Placebo - Salmeterol - Montelukast	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

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

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

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:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00245570 History of Changes
Other Study ID Numbers:	2005_043, MK0476-316
Study First Received:	October 26, 2005
Results First Received:	September 25, 2009
Last Updated:	May 27, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma, Exercise-Induced
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Montelukast
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012