The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00534976
First received: September 21, 2007
Last updated: June 16, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
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 More Information
Additional Information:
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President of Late Stage DevelopmentClinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00534976 History of Changes |
| Other Study ID Numbers: | MK-0476-377, 2007_586 |
| Study First Received: | September 21, 2007 |
| Results First Received: | March 11, 2011 |
| Last Updated: | June 16, 2011 |
| 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 May 16, 2013