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CompletedNCT00245570Updated Feb 2, 2022Results posted

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

A Phase 3 interventional study of Comparator: Montelukast and Comparator: Salmeterol 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
47
Allocation
Randomized
Ages
15 Years to 45 Years
Sex
All
01

Study 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.

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 47 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

  • Physician-diagnosed exercise-induced bronchospasm

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

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

Study arms

  • Experimental
    1

    Montelukast - Salmeterol - Placebo

    Drug: Comparator: Montelukast · Drug: Comparator: Salmeterol · Drug: Comparator: Placebo (montelukast) · Drug: Comparator: Placebo (salmeterol)

  • Experimental
    2

    Montelukast - Placebo - Salmeterol

    Drug: Comparator: Montelukast · Drug: Comparator: Salmeterol · Drug: Comparator: Placebo (montelukast) · Drug: Comparator: Placebo (salmeterol)

  • Experimental
    3

    Salmeterol - Montelukast - Placebo

    Drug: Comparator: Montelukast · Drug: Comparator: Salmeterol · Drug: Comparator: Placebo (montelukast) · Drug: Comparator: Placebo (salmeterol)

  • Experimental
    4

    Salmeterol - Placebo - Montelukast

    Drug: Comparator: Montelukast · Drug: Comparator: Salmeterol · Drug: Comparator: Placebo (montelukast) · Drug: Comparator: Placebo (salmeterol)

  • Experimental
    5

    Placebo - Montelukast - Salmeterol

    Drug: Comparator: Montelukast · Drug: Comparator: Salmeterol · Drug: Comparator: Placebo (montelukast) · Drug: Comparator: Placebo (salmeterol)

  • Experimental
    6

    Placebo - Salmeterol - Montelukast

    Drug: Comparator: Montelukast · Drug: Comparator: Salmeterol · Drug: Comparator: Placebo (montelukast) · Drug: Comparator: Placebo (salmeterol)

Interventions

  • DrugComparator: Montelukast

    1 dose montelukast 10 mg tablet given orally in one of three treatment periods

  • DrugComparator: Salmeterol

    1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods

  • DrugComparator: Placebo (montelukast)

    1 dose matching-image placebo to montelukast tablet in two of three treatment periods

  • DrugComparator: Placebo (salmeterol)

    1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

    Time frame: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose

  5. 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.

    Time frame: 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 0-60 Min) at 2 Hours Postdose

    The measure included only the area below the pre-exercise baseline

    Time frame: 0-60 minutes after the exercise challenge at 2 hours postdose

  7. Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose

    The measure included only the area below the pre-exercise baseline

    Time frame: 0-60 minutes after the exercise challenge at 8.5 hours postdose

  8. 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

    Time frame: 0-60 minutes after the exercise challenge 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 after exercise challenge 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 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.

    Time frame: Exercise challenge at 8.5 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 after exercise challenge 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 May 27, 2010

Participant flow

Patients were randomized at 5 sites (4 in the US and 1 in Peru). Primary therapy period: December 2005 to August 2006

Treatment Period II
Participant flow — Treatment Period II
MilestoneMontelukast/ Salmeterol/PlaceboMontelukast/ Placebo/ SalmeterolSalmeterol / Montelukast/ PlaceboSalmeterol/ Placebo/ MontelukastPlacebo/ Montelukast/ SalmeterolPlacebo/ Salmeterol/ Montelukast
Started788888
Completed788888
Not completed000000
Washout Between Periods II and III
Participant flow — Washout Between Periods II and III
MilestoneMontelukast/ Salmeterol/PlaceboMontelukast/ Placebo/ SalmeterolSalmeterol / Montelukast/ PlaceboSalmeterol/ Placebo/ MontelukastPlacebo/ Montelukast/ SalmeterolPlacebo/ Salmeterol/ Montelukast
Started788888
Completed788888
Not completed000000
Treatment Period III
Participant flow — Treatment Period III
MilestoneMontelukast/ Salmeterol/PlaceboMontelukast/ Placebo/ SalmeterolSalmeterol / Montelukast/ PlaceboSalmeterol/ Placebo/ MontelukastPlacebo/ Montelukast/ SalmeterolPlacebo/ Salmeterol/ Montelukast
Started788888
Completed788888
Not completed000000
Washout Between Periods III and IV
Participant flow — Washout Between Periods III and IV
MilestoneMontelukast/ Salmeterol/PlaceboMontelukast/ Placebo/ SalmeterolSalmeterol / Montelukast/ PlaceboSalmeterol/ Placebo/ MontelukastPlacebo/ Montelukast/ SalmeterolPlacebo/ Salmeterol/ Montelukast
Started788888
Completed778888
Not completed010000
Withdrew: Adverse event010000
Treatment Period IV
Participant flow — Treatment Period IV
MilestoneMontelukast/ Salmeterol/PlaceboMontelukast/ Placebo/ SalmeterolSalmeterol / Montelukast/ PlaceboSalmeterol/ Placebo/ MontelukastPlacebo/ Montelukast/ SalmeterolPlacebo/ Salmeterol/ Montelukast
Started778888
Completed778888
Not completed000000

Outcome measures

PrimaryMaximum 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.

Time frame:
0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Reported as:
Mean · Percent Change from Baseline
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)
Percent Change from BaselineMontelukast 10 mgSalmeterol 50-μgPlacebo
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)13.15 ± 10.2810.46 ± 9.9521.86 ± 13.44
SecondaryNumber 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
Reported as:
Number · Participants
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
ParticipantsMontelukast 10 mgSalmeterol 50-μgPlacebo
Patients Requiring Rescue Medication349
Patients Not Requiring Rescue Medication444238
SecondaryNumber 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
Reported as:
Number · Participants
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
ParticipantsMontelukast 10 mgSalmeterol 50-μgPlacebo
Patients Requiring Rescue Medication004
Patients Not Requiring Rescue Medication403933
SecondaryNumber 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
Reported as:
Number · Participants
Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
ParticipantsMontelukast 10 mgSalmeterol 50-μgPlacebo
Patients Requiring Rescue Medication366
Patients Not Requiring Rescue Medication434040
SecondaryMaximum 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.

Time frame:
0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose
Reported as:
Mean · Percent Change from Baseline
Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB
Percent Change from BaselineMontelukast 10 mgSalmeterol 50-μgPlacebo
Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB11.60 ± 9.6411.01 ± 7.5616.65 ± 12.76
SecondaryMaximum 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.

Time frame:
0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Reported as:
Mean · Percent Change from Baseline
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
Percent Change from BaselineMontelukast 10 mgSalmeterol 50-μgPlacebo
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB10.09 ± 11.1016.22 ± 13.0913.64 ± 9.67
SecondaryArea 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

Time frame:
0-60 minutes after the exercise challenge at 2 hours postdose
Reported as:
Mean · Percent * minutes
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
Percent * minutesMontelukast 10 mgSalmeterol 50-μgPlacebo
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 Postdose254.60 ± 241.17293.05 ± 362.33710.43 ± 529.91
SecondaryArea 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

Time frame:
0-60 minutes after the exercise challenge at 8.5 hours postdose
Reported as:
Mean · Percent * minutes
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
Percent * minutesMontelukast 10 mgSalmeterol 50-μgPlacebo
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 Postdose191.01 ± 166.24276.26 ± 226.37511.28 ± 566.30
SecondaryArea 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

Time frame:
0-60 minutes after the exercise challenge at 24 hours postdose
Reported as:
Mean · Percent * minutes
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
Percent * minutesMontelukast 10 mgSalmeterol 50-μgPlacebo
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 Postdose231.09 ± 413.73554.93 ± 649.52395.96 ± 464.92
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 after exercise challenge 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
MinutesMontelukast 10 mgSalmeterol 50-μgPlacebo
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose16.63 ± 23.7217.58 ± 27.8142.70 ± 34.26
SecondaryTime 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.

Time frame:
Exercise challenge at 8.5 hours postdose
Reported as:
Mean · Minutes
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose
MinutesMontelukast 10 mgSalmeterol 50-μgPlacebo
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose10.70 ± 13.3813.82 ± 18.3732.34 ± 34.57
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 after exercise challenge 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
MinutesMontelukast 10 mgSalmeterol 50-μgPlacebo
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose11.04 ± 20.8429.75 ± 33.5023.31 ± 29.30

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Montelukast/ Salmeterol/Placebo—0/7 (0%)0/7 (0%)
Montelukast/ Placebo/ Salmeterol—0/8 (0%)0/8 (0%)
Salmeterol / Montelukast/ Placebo—0/8 (0%)0/8 (0%)
Salmeterol/ Placebo/ Montelukast—0/8 (0%)0/8 (0%)
Placebo/ Montelukast/ Salmeterol—0/8 (0%)0/8 (0%)
Placebo/ Salmeterol/ Montelukast—0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall Study Population
Mean26.0 ± 7.92
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study Population
Female24
Male23
Need for β-agonist rescue medication following exercise challenge
Need for β-agonist rescue medication following exercise challenge(participants)Overall Study Population
No31
Yes16
Area under the FEV1 percent change from baseline time curve for 0-60 mins after exercise challenge
Area under the FEV1 percent change from baseline time curve for 0-60 mins after exercise challenge(% * minutes)Overall Study Population
Mean957.46 ± 518.69
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 Baseline)Overall Study Population
Mean27.75 ± 6.26
Time to recovery from maximal percent fall
Time to recovery from maximal percent fall(Minutes)Overall Study Population
Mean55.03 ± 32.62
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
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
NCT00245570
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 28, 2005
Start date
Dec 2005
Primary completion
Sep 2006
Completion
Sep 2006
Results posted
May 27, 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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Studies of the drugs tested here: Montelukast · Salmeterol Xinafoate

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