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

NCT00245570 | Completed Phase 3 Results

• 3 other identifiers: 0476-316MK0476-3162005_043
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma, Exercise-Induced

Outcome Measures

Primary Outcomes (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)

  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.

  0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

Secondary Outcomes (11)

• Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose

  0-90 minutes after the exercise challenge performed at 2 hours postdose

• Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose

  0-90 minutes after the exercise challenge performed at 8.5 hours postdose

• Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose

  0-90 minutes after the exercise challenge performed at 24 hours postdose

• Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB

  0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose

• Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB

  0-60 minutes after the exercise challenge performed 24 hours after a single oral dose

Study Arms (6)

1

EXPERIMENTAL

Montelukast - Salmeterol - Placebo

Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

2

EXPERIMENTAL

Montelukast - Placebo - Salmeterol

Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

3

EXPERIMENTAL

Salmeterol - Montelukast - Placebo

Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

4

EXPERIMENTAL

Salmeterol - Placebo - Montelukast

Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

5

EXPERIMENTAL

Placebo - Montelukast - Salmeterol

Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

6

EXPERIMENTAL

Placebo - Salmeterol - Montelukast

Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

Interventions

Comparator: Montelukast DRUG

1 dose montelukast 10 mg tablet given orally in one of three treatment periods

1; 2; 3; 4; 5; 6

Comparator: Salmeterol DRUG

1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods

1; 2; 3; 4; 5; 6

Comparator: Placebo (montelukast) DRUG

1 dose matching-image placebo to montelukast tablet in two of three treatment periods

1; 2; 3; 4; 5; 6

Comparator: Placebo (salmeterol) DRUG

1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Physician-diagnosed exercise-induced bronchospasm

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Philip G, Pearlman DS, Villaran 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. doi: 10.1378/chest.07-0550. Epub 2007 Jun 15.

  PMID: 17573489 BACKGROUND

MeSH Terms

Conditions

Asthma, Exercise-Induced

Interventions

montelukast; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 28, 2005
• Study Start: December 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 2, 2022
• Results First Posted: May 27, 2010

Record last verified: 2022-01