The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00534976
First received: September 21, 2007
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.


Condition Intervention Phase
Exercise-induced Bronchoconstriction (EIB)
Drug: Comparator: montelukast sodium
Drug: Comparator: Comparator: placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose [ Time Frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose ] [ Designated as safety issue: No ]
    Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.


Secondary Outcome Measures:
  • Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose [ Time Frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose ] [ Designated as safety issue: No ]
    Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.

  • Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose [ Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose ] [ Designated as safety issue: No ]
    AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.

  • Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose [ Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose ] [ Designated as safety issue: No ]
    AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.

  • Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose [ Time Frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose ] [ Designated as safety issue: No ]

    This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.

    Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins.

    The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication.


  • Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose [ Time Frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose ] [ Designated as safety issue: No ]
    This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication.

  • Number of Participants Requiring Rescue Medication at 2 Hours Postdose [ Time Frame: 0-90 minutes after the exercise challenge at 2 hours postdose ] [ Designated as safety issue: No ]
    This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication.

  • Number of Participants Requiring Rescue Medication at 24 Hours Postdose [ Time Frame: 0-90 minutes after the exercise challenge at 24 hours postdose ] [ Designated as safety issue: No ]
    This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication.


Enrollment: 364
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Montelukast Sodium

Participants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled)

Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo after a 3- to 7-day washout period

Drug: Comparator: montelukast sodium

Patients 4-5 years: 4 mg Montelukast chewable tablet daily

Patients 6-14 years: 5 mg chewable tablet daily

Experimental: Placebo

Participants 4-5 years: A single dose of 4 mg Pbo chewable tablet daily, crossing over to Montelukast 4 mg chewable tablet after a 3- to 7-day washout period (no participants 4-5 years of age were enrolled)

Participants 6-14 years: A single dose of 5 mg Pbo chewable tablet daily, crossing over to Montelukast 5 mg chewable tablet after a 3- to 7-day washout period

Drug: Comparator: Comparator: placebo (unspecified)

Patients 4-5 years: 4 mg Pbo chewable tablet daily

Patients 6-14 years: 5 mg Pbo chewable tablet daily


  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The child is 4 years to 14 years of age
  • The child is a non smoker
  • The child has exercise-induced bronchoconstriction (EIB)

Exclusion Criteria:

  • The child has active or chronic breathing disease, other than asthma
  • The child has required insertion of a breathing tube for asthma
  • The child had major surgery within the last 4 weeks
  • The child is currently in the hospital
  • The child has or had an upper respiratory tract infection within the last 2 weeks
  • The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
  • The child has been in a research study in the last 4 weeks
  • The child has stomach, brain, heart, kidney or liver disease
  • The child drinks more that 4 caffeinated drinks a day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534976

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00534976     History of Changes
Other Study ID Numbers: 0476-377, 2007_586
Study First Received: September 21, 2007
Results First Received: March 11, 2011
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014