NCT00092131

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

June 17, 2010

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

September 21, 2004

Results QC Date

September 24, 2009

Last Update Submit

February 1, 2022

Conditions

Asthma, Exercise-Induced

Outcome Measures

Primary Outcomes (1)

  • Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

    In Participants 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.

    Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

Secondary Outcomes (11)

  • Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose

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

  • Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose

    0-90 minutes after the exercise challenge performed at 12 hours postdose

  • Number of Participants Requiring ß-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 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

    Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose

  • Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

    Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Montelukast - Placebo

Drug: Comparator: MontelukastDrug: Comparator: Placebo

2

EXPERIMENTAL

Placebo - Montelukast

Drug: Comparator: MontelukastDrug: Comparator: Placebo

Interventions

Comparator: MontelukastDRUG

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

12
Comparator: PlaceboDRUG

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

12

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants with mild-to-moderate asthma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16892789BACKGROUND

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

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

September 21, 2004

First Posted

September 24, 2004

Study Start

June 1, 2003

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

February 2, 2022

Results First Posted

June 17, 2010

Record last verified: 2022-02