Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)

NCT ID: NCT00092131

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2003-11-30

Brief Summary

The purpose of this study is 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 participants who have a history of worsening asthma after exercise.

Conditions

Asthma, Exercise-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Montelukast - Placebo

Group Type: EXPERIMENTAL

Comparator: Montelukast

Intervention Type: DRUG

Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge

Comparator: Placebo

Intervention Type: DRUG

Placebo tablet administered orally as a single witnessed dose before exercise challenge

2

Placebo - Montelukast

Group Type: EXPERIMENTAL

Comparator: Montelukast

Intervention Type: DRUG

Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge

Comparator: Placebo

Intervention Type: DRUG

Placebo tablet administered orally as a single witnessed dose before exercise challenge

Interventions

Comparator: Montelukast

Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge

Intervention Type: DRUG

Comparator: Placebo

Placebo tablet administered orally as a single witnessed dose before exercise challenge

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants with mild-to-moderate asthma

Exclusion Criteria

• Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Pearlman DS, van Adelsberg J, Philip G, Tilles SA, Busse W, Hendeles L, Loeys T, Dass SB, Reiss TF. Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast. Ann Allergy Asthma Immunol. 2006 Jul;97(1):98-104. doi: 10.1016/S1081-1206(10)61377-4.

Reference Type: BACKGROUND

PMID: 16892789 (View on PubMed)

Other Identifiers

MK0476-270

Identifier Type: -

Identifier Source: secondary_id

2004_026

Identifier Type: -

Identifier Source: secondary_id

0476-270

Identifier Type: -

Identifier Source: org_study_id