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Completed

NCT Number: NCT00534976

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

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.

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Key information

Conditions

Exercise-Induced Bronchoconstriction (EIB)

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: montelukast sodium

Drug

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

Patients 6-14 years: 5 mg chewable tablet daily

Comparator: Comparator: placebo (unspecified)

Drug

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

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

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. Number of Participants Requiring Rescue Medication at 2 Hours Postdose

    Time frame: 0-90 minutes after the exercise challenge at 2 hours postdose

    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.

  7. Number of Participants Requiring Rescue Medication at 24 Hours Postdose

    Time frame: 0-90 minutes after the exercise challenge at 24 hours postdose

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2007
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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