The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exercise-induced Bronchoconstriction (EIB)
Intervention: montelukast sodium (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: The change from pre-exercise baseline spirometry reading to the maximum fall in the spirometry reading (FEV1) during one exercise challenge with montelukast compared to another challenge with placebo
Secondary outcome: The time the maximum fall in the spirometry reading (FEV1) takes to return to the baseline measurement
Eligibility
Minimum age: 4 Years.
Maximum age: 14 Years.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, San Juan 00917, Puerto Rico; Recruiting
Call for Information, Commerce, California 90040, United States; Recruiting
Call for Information, Denver, Colorado 80230, United States; Recruiting
Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400
Merck Sharp & Dohme IDEA, Inc., Tallinn, Eesti 11415, Estonia; Recruiting
Andrius Bacevicius, Phone: 370-5-2780-243
Call for Information, Tampa, Florida 33613-0000, United States; Recruiting
Call for Information, Tallahassee, Florida 32308, United States; Recruiting
Call for Information, Orange City, Florida 32763, United States; Recruiting
Call for Information, Canton, Ohio 44718-2784, United States; Recruiting
Call for Information, Oklahoma City, Oklahoma 73120, United States; Recruiting
Call for Information, Collegeville, Pennsylvania 19426, United States; Recruiting
Call for Information, Blue Bell, Pennsylvania 19422-0000, United States; Recruiting
Call for Information, Chattanoga, Tennessee 37421, United States; Recruiting
Call for Information, Layton, Utah 84041, United States; Recruiting
Call for Information, Burke, Virginia 22015, United States; Recruiting
Call for Information, Seattle, Washington 98105-0000, United States; Recruiting
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: February 2008
Ending date: March 2010
Last updated: October 14, 2009
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