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CompletedNCT00127166Updated May 10, 2024Results posted

Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

A Phase 3 interventional study of Montelukast sodium and Salmeterol xinafoate in Exercise Induced Asthma, sponsored by Organon and Co. Completed. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-05-10.

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

Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
6 Years to 14 Years
Sex
All
01

Study summary

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.

02

Conditions studied

  • Exercise Induced Asthma
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 154 is above 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
6 Years to 14 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

  • 6-14 year old children with a history of asthma for at least 12 months
  • must demonstrate airway constriction brought on by exercise

Exclusion criteria

Exclusion Criteria:

  • is taking any medications that are not allowed in the study
05

Study design

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

Study arms

  • Experimental
    Montelukast/Salmeterol

    Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

    Drug: Montelukast sodium · Drug: Salmeterol xinafoate · Drug: Fluticasone propionate · Drug: Montelukast matching placebo · Drug: Salmeterol matching placebo

  • Experimental
    Salmeterol/Montelukast

    Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

    Drug: Montelukast sodium · Drug: Salmeterol xinafoate · Drug: Fluticasone propionate · Drug: Montelukast matching placebo · Drug: Salmeterol matching placebo

Interventions

  • DrugMontelukast sodium

    Montelukast 5 mg chewable tablet once daily

  • DrugSalmeterol xinafoate

    Salmeterol 50 mcg dry powder per actuation inhaled twice daily

  • DrugFluticasone propionate

    Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily

  • DrugMontelukast matching placebo

    Matching placebo to montelukast oral tablet administered once daily.

  • DrugSalmeterol matching placebo

    Matching placebo to salmeterol dry powder for inhalation administered twice daily

06

What researchers measure

Primary outcomes

  1. Maximum Post-exercise Percent (%) Fall in FEV1

    The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.

    Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

Secondary outcomes

  1. Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))

    The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.

    Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

  2. Maximum FEV1 % Predicted Following First Beta-agonist Use

    The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.

    Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

  3. Time to Recovery to Within 5% of Baseline FEV1

    The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.

    Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

  4. Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use

    The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.

    Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

07

Results

Posted Dec 3, 2009

Participant flow

Multicenter Study (30 Ex-US sites) Study Initiation Date: December 22, 2005 Study Completion Date: November 14, 2008

Period I
Participant flow — Period I
MilestoneMontelukast / SalmeterolSalmeterol / Montelukast
Started7876
Completed7574
Not completed32
Withdrew: Protocol violation02
Withdrew: Withdrawal by subject20
Withdrew: Patient did not meet inclusion criteria10
Washout Period
Participant flow — Washout Period
MilestoneMontelukast / SalmeterolSalmeterol / Montelukast
Started7574
Completed7573
Not completed01
Withdrew: Patient did not meet inclusion criteria01
Period II
Participant flow — Period II
MilestoneMontelukast / SalmeterolSalmeterol / Montelukast
Started7573
Completed7273
Not completed30
Withdrew: Withdrawal by subject20
Withdrew: Patient did not perform visit 6 exercise10

Outcome measures

PrimaryMaximum Post-exercise Percent (%) Fall in FEV1

The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.

Time frame:
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Reported as:
Least squares mean · Percent change from baseline
Maximum Post-exercise Percent (%) Fall in FEV1
Percent change from baselineMontelukastSalmeterol
Maximum Post-exercise Percent (%) Fall in FEV110.57 (8.86 to 12.27)13.82 (12.11 to 15.52)
Statistical analysis
  • Montelukast vs Salmeterol · ANOVA · p = 0.009 · Least squares mean difference: -3.25 · 95% CI -5.66 to -0.84Model terms: participant, treatment and period. The treatment test is adjusted for period
SecondaryArea Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.

Time frame:
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Reported as:
Least squares mean · Percent times Minutes
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
Percent times MinutesMontelukastSalmeterol
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))116.04 (89.95 to 142.24)168.75 (142.56 to 194.95)
Statistical analysis
  • Montelukast vs Salmeterol · ANOVA · p = 0.006 · Least squares mean difference: -52.71 · 95% CI -89.76 to -15.66Model terms: participant, treatment and period. The treatment test is adjusted for period.
SecondaryMaximum FEV1 % Predicted Following First Beta-agonist Use

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.

Time frame:
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Reported as:
Least squares mean · Percent of predicted value
Maximum FEV1 % Predicted Following First Beta-agonist Use
Percent of predicted valueMontelukastSalmeterol
Maximum FEV1 % Predicted Following First Beta-agonist Use104.03 (102.83 to 105.23)99.92 (98.72 to 101.12)
Statistical analysis
  • Montelukast vs Salmeterol · ANCOVA · p = <0.001 · Least squares mean difference: 4.11 · 95% CI 2.58 to 5.64Participant, treatment, period \& covariate for FEV1 %-predicted Treatment test is adjusted for period \& FEV1 %-predicted at pre-exercise baseline
SecondaryTime to Recovery to Within 5% of Baseline FEV1

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.

Time frame:
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Reported as:
Median · minutes
Time to Recovery to Within 5% of Baseline FEV1
minutesMontelukastSalmeterol
Time to Recovery to Within 5% of Baseline FEV15.9 (0.0 to 19.12)11.1 (0.065 to 22.94)
Statistical analysis
  • Montelukast vs Salmeterol · Cox Proportional Hazards Model · p = 0.035 · Hazard ratio (hr): 1.26 · 95% CI 1.02 to 1.55Dispersion not applicable to time to event data
SecondaryAverage (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.

Time frame:
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Reported as:
Least squares mean · Percent change from baseline
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
Percent change from baselineMontelukastSalmeterol
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use6.51 (5.44 to 7.59)2.72 (1.64 to 3.79)
Statistical analysis
  • Montelukast vs Salmeterol · ANOVA · p = <0.001 · Least squares mean difference: 3.80 · 95% CI 2.28 to 5.32Model terms: participant, treatment and period. The treatment test is adjusted for period.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Montelukast—1/150 (0.7%)27/150 (18%)
Salmeterol—1/150 (0.7%)21/150 (14%)
Most frequent serious events
Most frequent serious events
EventMontelukastSalmeterol
Accidental OverdoseInjury, poisoning and procedural complications0/1501/150
OverdoseInjury, poisoning and procedural complications1/1500/150
Most frequent other events
Showing 10 of 34
Most frequent other events
EventMontelukastSalmeterol
PharyngitisInfections and infestations5/1503/150
AsthmaRespiratory, thoracic and mediastinal disorders4/1504/150
TonsillitisInfections and infestations3/1502/150
DiarrhoeaGastrointestinal disorders2/1500/150
PyrexiaGeneral disorders0/1502/150
NasopharyngitisInfections and infestations2/1501/150
PertussisInfections and infestations2/1500/150
Viral InfectionInfections and infestations0/1502/150
HeadacheNervous system disorders2/1500/150
ConjunctivitisEye disorders1/1500/150

Baseline characteristics

Age, Continuous
Age, Continuous(years)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Mean10.2 ± 2.09.8 ± 2.010.0 ± 2.0
Sex: Female, Male
Sex: Female, Male(Participants)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Female353065
Male434689
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Asian101
Black11718
White384179
Other282856
Area Under the Curve from 0 to 20 minutes (AUC0-20)
Area Under the Curve from 0 to 20 minutes (AUC0-20)(Percent times Minutes)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Mean320.08 ± 208.62317.74 ± 165.71318.93 ± 188.06
Avg %-change from pre-exercise baseline FEV1 after 1st β-agonist use & prior to 2nd β-agonist use
Avg %-change from pre-exercise baseline FEV1 after 1st β-agonist use & prior to 2nd β-agonist use(Percent change from baseline)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Mean1.36 ± 10.994.78 ± 10.923.05 ± 11.05
Maximum FEV1 percent predicted
Maximum FEV1 percent predicted(Percent of predicted value)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Mean99.88 ± 32.45100.54 ± 15.61100.21 ± 25.49
Maximum percent fall in FEV1 after exercise
Maximum percent fall in FEV1 after exercise(Percent change from baseline)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Mean24.77 ± 10.2525.42 ± 9.0425.09 ± 9.65
Time to recovery
Time to recovery(Minutes)Montelukast / SalmeterolSalmeterol / MontelukastTotal
Mean23.53 ± 10.5321.51 ± 8.3022.53 ± 9.51
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011. PubMed 20568384 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00127166
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 5, 2005
Start date
Dec 2005
Primary completion
Nov 2008
Completion
Nov 2008
Results posted
Dec 3, 2009
Last update
May 10, 2024

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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