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

NCT ID: NCT00534976

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-03-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Comparator: montelukast sodium

Intervention Type: DRUG

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

Patients 6-14 years: 5 mg chewable tablet daily

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

Group Type: EXPERIMENTAL

Comparator: Comparator: placebo (unspecified)

Intervention Type: DRUG

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

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

Interventions

Comparator: montelukast sodium

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

Patients 6-14 years: 5 mg chewable tablet daily

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 22221440 (View on PubMed)

Other Identifiers

2007_586

Identifier Type: -

Identifier Source: secondary_id

0476-377

Identifier Type: -

Identifier Source: org_study_id