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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00534976

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 III

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:

MedlinePlus related topics: Exercise and Physical Fitness

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534976

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

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 February 09, 2012