Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

• ClinicalTrials.gov Identifier: NCT00245570
• Recruitment Status: Completed
• First Posted: October 28, 2005
• Results First Posted: May 27, 2010
• Last Update Posted: February 2, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma, Exercise-Induced	Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, 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
• Study Start Date: December 2005
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: September 2006

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
   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.
5. 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 ]
   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.
6. 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 ]

   The measure included only the area below the pre-exercise

   baseline

7. 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 ]
   The measure included only the area below the pre-exercise baseline
8. 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 ]
   The measure included only the area below the pre-exercise baseline
9. Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose [ Time Frame: Exercise challenge at 2 hours postdose ]
   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.
10. 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 ]

    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.

11. Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose [ Time Frame: Exercise challenge at 24 hours postdose ]

    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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

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: Organon and Co
• ClinicalTrials.gov Identifier: NCT00245570
• Other Study ID Numbers: 0476-316; MK0476-316; 2005_043
• First Posted: October 28, 2005
• Results First Posted: May 27, 2010
• Last Update Posted: February 2, 2022
• Last Verified: January 2022

Additional relevant MeSH terms:

Asthma, Exercise-Induced; Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Salmeterol Xinafoate; Montelukast; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers