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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127166
First received: June 30, 2005
Last updated: August 24, 2015
Last verified: August 2015

June 30, 2005
August 24, 2015
December 2005
November 2008   (final data collection date for primary outcome measure)
Maximum Post-exercise Percent (%) Fall in FEV1 [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00127166 on ClinicalTrials.gov Archive Site
  • Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20)) [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
    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.
  • Maximum FEV1 % Predicted Following First Beta-agonist Use [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
    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 to Recovery to Within 5% of Baseline FEV1 [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
    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.
  • Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use [ Time Frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10) ] [ Designated as safety issue: No ]
    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.
Not Provided
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Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Exercise Induced Asthma
  • Drug: Montelukast sodium
    Montelukast 5 mg chewable tablet once daily
  • Drug: Salmeterol xinafoate
    Salmeterol 50 mcg dry powder per actuation inhaled twice daily
  • Drug: Fluticasone propionate
    Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
  • Drug: Montelukast matching placebo
    Matching placebo to montelukast oral tablet administered once daily.
  • Drug: Salmeterol matching placebo
    Matching placebo to salmeterol dry powder for inhalation administered twice daily
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: Montelukast sodium
    • Drug: Salmeterol xinafoate
    • Drug: Fluticasone propionate
    • Drug: Montelukast matching placebo
    • Drug: Salmeterol matching placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
November 2008
November 2008   (final data collection date for primary outcome measure)

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:

  • is taking any medications that are not allowed in the study
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Brazil,   Colombia,   Croatia,   Estonia,   Greece,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Spain
 
NCT00127166
0476-911, 2004_006
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP