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

NCT ID: NCT00245570

Last Updated: 2022-02-02

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma, Exercise-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Montelukast - Salmeterol - Placebo

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Comparator: Salmeterol

Intervention Type DRUG

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

Comparator: Placebo (montelukast)

Intervention Type DRUG

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

Comparator: Placebo (salmeterol)

Intervention Type DRUG

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

2

Montelukast - Placebo - Salmeterol

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Comparator: Salmeterol

Intervention Type DRUG

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

Comparator: Placebo (montelukast)

Intervention Type DRUG

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

Comparator: Placebo (salmeterol)

Intervention Type DRUG

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

3

Salmeterol - Montelukast - Placebo

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Comparator: Salmeterol

Intervention Type DRUG

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

Comparator: Placebo (montelukast)

Intervention Type DRUG

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

Comparator: Placebo (salmeterol)

Intervention Type DRUG

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

4

Salmeterol - Placebo - Montelukast

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Comparator: Salmeterol

Intervention Type DRUG

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

Comparator: Placebo (montelukast)

Intervention Type DRUG

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

Comparator: Placebo (salmeterol)

Intervention Type DRUG

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

5

Placebo - Montelukast - Salmeterol

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Comparator: Salmeterol

Intervention Type DRUG

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

Comparator: Placebo (montelukast)

Intervention Type DRUG

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

Comparator: Placebo (salmeterol)

Intervention Type DRUG

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

6

Placebo - Salmeterol - Montelukast

Group Type EXPERIMENTAL

Comparator: Montelukast

Intervention Type DRUG

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

Comparator: Salmeterol

Intervention Type DRUG

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

Comparator: Placebo (montelukast)

Intervention Type DRUG

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

Comparator: Placebo (salmeterol)

Intervention Type DRUG

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

Interventions

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Comparator: Montelukast

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

Intervention Type DRUG

Comparator: Salmeterol

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

Intervention Type DRUG

Comparator: Placebo (montelukast)

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

Intervention Type DRUG

Comparator: Placebo (salmeterol)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type BACKGROUND
PMID: 17573489 (View on PubMed)

Other Identifiers

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MK0476-316

Identifier Type: -

Identifier Source: secondary_id

2005_043

Identifier Type: -

Identifier Source: secondary_id

0476-316

Identifier Type: -

Identifier Source: org_study_id

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