Asthma, Exercise-InducedPhase 3NCT00092131

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

A Phase 3 study testing Comparator: Montelukast in people with Asthma, Exercise-Induced, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 15 to 45 years
Conditions the study is for: Asthma, Exercise-Induced
What is being tested?: Comparator: Montelukast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: No sites listed yet
Study dates: Jun 2003to Nov 2003
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Participants with mild-to-moderate asthma

Who cannot join

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

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm

Conditions: Asthma, Exercise-Induced
Being tested: Comparator: Montelukast, Comparator: Placebo
Medical subject headings: Asthma, Exercise-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: MontelukastDrug
Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
Comparator: PlaceboDrug
Placebo tablet administered orally as a single witnessed dose before exercise challenge

Study groups in NCT00092131
Study group	Role	What they receive
1	Experimental	Montelukast - Placebo Receives: Drug: Comparator: Montelukast; Drug: Comparator: Placebo
2	Experimental	Placebo - Montelukast Receives: Drug: Comparator: Montelukast; Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Measured: 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)
In patients with EIB, the percent change from pre-exercise baseline FEV1 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.
Measured: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose
The measure included only the area below the pre-exercise baseline.
Measured: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose
The measure included only the area below the pre-exercise baseline.
Measured: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose
The measure included only the area below the pre-exercise baseline.
Measured: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After 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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Measured: Exercise challenge at 2 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Measured: Exercise challenge at 12 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After 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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Measured: Exercise challenge at 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Nov 2003

First posted24 Sep 2004 (estimated)
Study startJun 2003
Primary completionNov 2003
Study completionNov 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Asthma, Exercise-InducedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00092131
Sponsor's protocol ID: 0476-270
Other IDs: MK0476-270, 2004_026
Status last verified: Feb 2022
First submitted: 21 Sep 2004
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 16892789

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease
COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis)
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
Asthma in Children, Exercise Induced Asthma

All Asthma, Exercise-Induced trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm
ClinicalTrials.gov ID: NCT00092131
Acronym / sponsor ID: 0476-270
Conditions: Asthma, Exercise-Induced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jun 2003
Primary completion: Nov 2003 (actual)
Study completion: Nov 2003 (actual)
First posted: 24 Sep 2004 (estimated)
Results: Posted 17 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: PlaceboMontelukast - Placebo
2	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: PlaceboPlacebo - Montelukast

Who may qualify

Ages: 15 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Participants with mild-to-moderate asthma

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparator: MontelukastMontelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge	Drug	1, 2
Comparator: PlaceboPlacebo tablet administered orally as a single witnessed dose before exercise challenge	Drug	1, 2

Primary outcome

Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
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.

11 secondary outcomes

Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose
Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose
Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose
Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
Time frame: Exercise challenge at 2 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
Time frame: Exercise challenge at 12 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
Time frame: Exercise challenge at 24 hours postdose

Results and safety

Results posted to the registry on 17 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Montelukast 10 mg in Period I Then Placebo in Period II	25	24
Placebo in Period I Then Montelukast 10 mg in Period II	26	26

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

Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose. Mean (Standard Deviation). Unit: Percent Change

Measure	Placebo n = 49	Montelukast 10 mg n = 49
Value	22.33 (13.10)	10.80 (7.88)

Population analysed: The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: During Period I and II (2 day treatment periods) and the 3 to 7 day crossover washout period, and up to and including 14 days after the last dose of study therapy.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast 10 mg in Period I Then Placebo in Period II	0 of 25 (0%)	0 of 25 (0%)	Not reported
Placebo in Period I Then Montelukast 10 mg in Period II	0 of 26 (0%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16892789Pearlman 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.

Related trials for Asthma, Exercise-Induced

Not yet recruitingObservational study
Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease
COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis)
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
Asthma in Children, Exercise Induced Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: Montelukast in people with Asthma, Exercise-Induced, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) (time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00092131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.

Trial summary

Key requirements

Who may be able to join

Who cannot join

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (1 listed)

Key exclusion criteria (1 listed)

Interventions

Primary outcome

Results and safety

Participant flow

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

Adverse events

Research links

Related trials for Asthma, Exercise-Induced

Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease

Swiss Paediatric Airway Cohort

The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception

Referral and contact

Questions about this trial

Participant flow

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

Adverse events