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

NCT00534976 | Completed Phase 4 Results

• 2 other identifiers: 0476-3772007_586
• Study Type: interventional
• Target: 364
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Exercise-induced Bronchoconstriction (EIB)

Outcome Measures

Primary Outcomes (1)

• Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose

  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.

  Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose

Secondary Outcomes (7)

• Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose

  Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose

• 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

  Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose

• 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

  Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose

• Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose

  0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose

• Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose

  0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose

Study Arms (2)

Montelukast Sodium

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

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)

Interventions

Comparator: montelukast sodium DRUG

Patients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily

Montelukast Sodium

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

Placebo

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Wasfi YS, Kemp JP, Villaran C, Massaad R, Xin W, Smugar SS, Knorr BA, Philip G. Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast. Allergy Asthma Proc. 2011 Nov-Dec;32(6):453-9. doi: 10.2500/aap.2011.32.3482.

  PMID: 22221440 DERIVED

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 13, 2024
• Results First Posted: April 7, 2011

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share