A Study of MK0476 to Prevent Exercise-Induced Bronchospasm - 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:	Prevention, Randomized, Double Blind (Subject, Investigator), 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

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 [ Time Frame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose ] [ Designated as safety issue: No ]

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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]

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
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Experimental 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
5: Experimental 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
6: Experimental 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

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

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:	September 21, 2009
ClinicalTrials.gov Identifier:	NCT00245570 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Bronchial Diseases
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic Agonists
Leukotriene Antagonists
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Montelukast
Asthma, Exercise-Induced
Autonomic Agents
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010