Asthma, Exercise-InducedPhase 3NCT00245570

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

A Phase 3 study testing Comparator: Montelukast and Comparator: Salmeterol 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.

Official record

Search all trials

Trial 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. 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 and Comparator: Salmeterol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: No sites listed yet
Study dates: Dec 2005to Sep 2006
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

Physician-diagnosed exercise-induced bronchospasm

Who cannot join

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.

About this study

Official title: A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction

Conditions: Asthma, Exercise-Induced
Being tested: Comparator: Montelukast, Comparator: Salmeterol, Comparator: Placebo (montelukast), Comparator: Placebo (salmeterol)
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
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Comparator: SalmeterolDrug
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Comparator: Placebo (montelukast)Drug
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Comparator: Placebo (salmeterol)Drug
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

Study groups in NCT00245570
Study group	Role	What they receive
1	Experimental	Montelukast - Salmeterol - Placebo Receives: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)
2	Experimental	Montelukast - Placebo - Salmeterol Receives: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)
3	Experimental	Salmeterol - Montelukast - Placebo Receives: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)
4	Experimental	Salmeterol - Placebo - Montelukast Receives: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)
5	Experimental	Placebo - Montelukast - Salmeterol Receives: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)
6	Experimental	Placebo - Salmeterol - Montelukast Receives: Drug: Comparator: Montelukast; Drug: Comparator: Salmeterol; Drug: Comparator: Placebo (montelukast); Drug: Comparator: Placebo (salmeterol)

What is being measured

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

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Measured: 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
In patients with EIB, the percent change from pre-exercise baseline FEV, 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: 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 0-60 Min) at 2 Hours Postdose
The measure included only the area below the pre-exercise
baseline
Measured: 0-60 minutes after the exercise challenge at 2 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose
The measure included only the area below the pre-exercise baseline
Measured: 0-60 minutes after the exercise challenge at 8.5 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose
The measure included only the area below the pre-exercise baseline
Measured: 0-60 minutes after the exercise challenge 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 after exercise challenge 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 8.5 Hours Postdose
The time to recovery from maximum percent fall is the
duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the
time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Measured: Exercise challenge at 8.5 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 after exercise challenge 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.

Dec 2005Sep 2006

First posted28 Oct 2005 (estimated)
Study startDec 2005
Primary completionSep 2006
Study completionSep 2006

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: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00245570
Sponsor's protocol ID: 0476-316
Other IDs: MK0476-316, 2005_043
Status last verified: Jan 2022
First submitted: 26 Oct 2005
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17573489

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 Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction
ClinicalTrials.gov ID: NCT00245570
Acronym / sponsor ID: 0476-316
Conditions: Asthma, Exercise-Induced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 28 Oct 2005 (estimated)
Results: Posted 27 May 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: 6

Arm	Type	Receives
1	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: Salmeterol, Drug: Comparator: Placebo (montelukast), Drug: Comparator: Placebo (salmeterol)Montelukast - Salmeterol - Placebo
2	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: Salmeterol, Drug: Comparator: Placebo (montelukast), Drug: Comparator: Placebo (salmeterol)Montelukast - Placebo - Salmeterol
3	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: Salmeterol, Drug: Comparator: Placebo (montelukast), Drug: Comparator: Placebo (salmeterol)Salmeterol - Montelukast - Placebo
4	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: Salmeterol, Drug: Comparator: Placebo (montelukast), Drug: Comparator: Placebo (salmeterol)Salmeterol - Placebo - Montelukast
5	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: Salmeterol, Drug: Comparator: Placebo (montelukast), Drug: Comparator: Placebo (salmeterol)Placebo - Montelukast - Salmeterol
6	Experimental	Drug: Comparator: Montelukast, Drug: Comparator: Salmeterol, Drug: Comparator: Placebo (montelukast), Drug: Comparator: Placebo (salmeterol)Placebo - Salmeterol - Montelukast

Who may qualify

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

Key inclusion criteria (1 listed)

Physician-diagnosed exercise-induced bronchospasm

Key exclusion criteria (1 listed)

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.

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: Montelukast1 dose montelukast 10 mg tablet given orally in one of three treatment periods	Drug	1, 2, 3, 4, 5, 6
Comparator: Salmeterol1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods	Drug	1, 2, 3, 4, 5, 6
Comparator: Placebo (montelukast)1 dose matching-image placebo to montelukast tablet in two of three treatment periods	Drug	1, 2, 3, 4, 5, 6
Comparator: Placebo (salmeterol)1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods	Drug	1, 2, 3, 4, 5, 6

Primary outcome

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)
Time frame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
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.

11 secondary outcomes

Number of Patients Requiring β-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 Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 0-60 Min) at 2 Hours Postdose
Time frame: 0-60 minutes after the exercise challenge at 2 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose
Time frame: 0-60 minutes after the exercise challenge at 8.5 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose
Time frame: 0-60 minutes after the exercise challenge 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 8.5 Hours Postdose
Time frame: Exercise challenge at 8.5 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 27 May 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/ Salmeterol/Placebo	7	7
Montelukast/ Placebo/ Salmeterol	8	8
Salmeterol / Montelukast/ Placebo	8	8
Salmeterol/ Placebo/ Montelukast	8	8
Placebo/ Montelukast/ Salmeterol	8	8
Placebo/ Salmeterol/ Montelukast	8	8

Primary outcome: 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)

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

Measure	Montelukast 10 mg n = 47	Salmeterol 50-μg n = 46	Placebo n = 47
Value	13.15 (10.28)	10.46 (9.95)	21.86 (13.44)

Population analysed: The primary efficacy analysis used the 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: Periods II through IV and washout periods in between these treatment periods, 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/ Salmeterol/Placebo	0 of 7 (0%)	0 of 7 (0%)	Not reported
Montelukast/ Placebo/ Salmeterol	0 of 8 (0%)	0 of 8 (0%)	Not reported
Salmeterol / Montelukast/ Placebo	0 of 8 (0%)	0 of 8 (0%)	Not reported
Salmeterol/ Placebo/ Montelukast	0 of 8 (0%)	0 of 8 (0%)	Not reported
Placebo/ Montelukast/ Salmeterol	0 of 8 (0%)	0 of 8 (0%)	Not reported
Placebo/ Salmeterol/ Montelukast	0 of 8 (0%)	0 of 8 (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 17573489Philip 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.

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 and Comparator: Salmeterol 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 27 May 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 Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB) (time frame: 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 NCT00245570, 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 Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (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 Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)

Adverse events