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CompletedNCT00092131Updated Feb 2, 2022Results posted

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

A Phase 3 interventional study of Comparator: Montelukast and Comparator: Placebo in Asthma, Exercise-Induced, sponsored by Organon and Co. Completed. Open to participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-02-02.

Sponsored by Organon and Co · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
15 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma, Exercise-Induced
03

In context

Asthma, Exercise-Induced

52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

This study's enrollment of 51 is close to the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Browse Organon & Co. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with mild-to-moderate asthma

Exclusion criteria

Exclusion Criteria:

  • Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    1

    Montelukast - Placebo

    Drug: Comparator: Montelukast · Drug: Comparator: Placebo

  • Experimental
    2

    Placebo - Montelukast

    Drug: Comparator: Montelukast · Drug: Comparator: Placebo

Interventions

  • DrugComparator: Montelukast

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

  • DrugComparator: Placebo

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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

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

  5. 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.

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

  6. 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.

    Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose

  7. 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.

    Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose

  8. 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.

    Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose

  9. 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.

    Time frame: Exercise challenge at 2 hours postdose

  10. 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.

    Time frame: Exercise challenge at 12 hours postdose

  11. 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.

    Time frame: Exercise challenge at 24 hours postdose

07

Results

Posted Jun 17, 2010

Participant flow

Patients were randomized at 9 sites. Primary therapy period: July to November 2003

Treatment Period I
Participant flow — Treatment Period I
MilestoneMontelukast 10 mg in Period I Then Placebo in Period IIPlacebo in Period I Then Montelukast 10 mg in Period II
Started2526
Completed2426
Not completed10
Withdrew: Adverse event10
Treatment Period II
Participant flow — Treatment Period II
MilestoneMontelukast 10 mg in Period I Then Placebo in Period IIPlacebo in Period I Then Montelukast 10 mg in Period II
Started2426
Completed2425
Not completed01
Withdrew: Adverse event01

Outcome measures

PrimaryMaximum 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.

Time frame:
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Reported as:
Mean · Percent Change
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Percent ChangePlaceboMontelukast 10 mg
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)22.33 ± 13.1010.80 ± 7.88
SecondaryNumber 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
Reported as:
Number · Participants
Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
ParticipantsPlaceboMontelukast 10 mg
Number of Patients Requiring Rescue Medication71
Number of Patients Not Requiring Rescue Medication4248
SecondaryNumber 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
Reported as:
Number · Participants
Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
ParticipantsPlaceboMontelukast 10 mg
Number of Patients Requiring Rescue Medication51
Number of Patients Not Requiring Rescue Medication4347
SecondaryNumber 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
Reported as:
Number · Participants
Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
ParticipantsPlaceboMontelukast 10 mg
Number of Patients Requiring Rescue Medication31
Number of Patients Not Requiring Rescue Medication4345
SecondaryMaximum 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.

Time frame:
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
Reported as:
Mean · Percent Change
Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Percent ChangePlaceboMontelukast 10 mg
Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)16.12 ± 10.238.35 ± 7.50
SecondaryMaximum 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.

Time frame:
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Reported as:
Mean · Percent Change
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Percent ChangePlaceboMontelukast 10 mg
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)16.86 ± 11.698.33 ± 7.34
SecondaryArea 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.

Time frame:
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
Reported as:
Mean · (percent change) *minutes
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
(percent change) *minutesPlaceboMontelukast 10 mg
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose702.13 ± 674.98182.46 ± 235.94
SecondaryArea 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.

Time frame:
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Reported as:
Mean · (percent change) *minutes
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
(percent change) *minutesPlaceboMontelukast 10 mg
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose389.55 ± 317.09152.27 ± 179.49
SecondaryArea 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.

Time frame:
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose
Reported as:
Mean · (percent change) *minutes
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
(percent change) *minutesPlaceboMontelukast 10 mg
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose409.50 ± 426.55120.06 ± 119.77
SecondaryTime 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.

Time frame:
Exercise challenge at 2 hours postdose
Reported as:
Mean · Minutes
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
MinutesPlaceboMontelukast 10 mg
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose37.67 ± 32.4410.82 ± 16.43
SecondaryTime 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.

Time frame:
Exercise challenge at 12 hours postdose
Reported as:
Mean · Minutes
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
MinutesPlaceboMontelukast 10 mg
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose24.50 ± 25.717.97 ± 12.68
SecondaryTime 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.

Time frame:
Exercise challenge at 24 hours postdose
Reported as:
Mean · Minutes
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
MinutesPlaceboMontelukast 10 mg
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose23.14 ± 26.135.74 ± 8.36

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Montelukast 10 mg in Period I Then Placebo in Period II—0/25 (0%)0/25 (0%)
Placebo in Period I Then Montelukast 10 mg in Period II—0/26 (0%)0/26 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall Study Population
Mean24.5 ± 5.9
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study Population
Female27
Male24
Need for β-agonist rescue medication following exercise challenge
Need for β-agonist rescue medication following exercise challenge(Participants)Overall Study Population
No47
Yes4
AUC for percent change from pre-exercise measurement FEV1 in L 0-60 mins after exercise challenge
AUC for percent change from pre-exercise measurement FEV1 in L 0-60 mins after exercise challenge((percent change) *minutes)Overall Study Population
Mean762.59 ± 380.34
Maximum Percent Fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge
Maximum Percent Fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge(Percent change from pre-exercise measure)Overall Study Population
Mean27.63 ± 5.60
Time to recovery from maximal percent fall in FEV1 after exercise challenge
Time to recovery from maximal percent fall in FEV1 after exercise challenge(Minutes)Overall Study Population
Mean45.15 ± 29.70
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2003, a primary completion of Nov 2003 and a completion of Nov 2003. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2010, 6 years 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2004
First posted
Sep 24, 2004
Start
Jun 2003
Primary completionActual
Nov 2003
CompletionActual
Nov 2003
Results first posted
Jun 17, 2010
Last update
Feb 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00092131
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 24, 2004
Start date
Jun 2003
Primary completion
Nov 2003
Completion
Nov 2003
Results posted
Jun 17, 2010
Last update
Feb 2, 2022

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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