Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Asthmatic Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exercise Induced Asthma
Intervention: montelukast sodium (Drug); Comparator: salmeterol (Drug); Comparator: fluticasone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to determine the effect of four weeks of treatment with two
investigational drugs (oral versus inhaled administration) plus an inhaled medication in the
treatment of airway constriction brought on by exercise in asthmatic patients.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Percent reduction of FEV1 measured by serial spirometry measurements followed exercise challenge
Secondary outcome: After exercise: reduction in AUC (0-20) min of percent change in FEV1; increase in maximum predicted FEV1; time to recovery of FEV1; increase in average predicted FEV1
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 6-14 year old children with a history of asthma for at least 12 months.
- Patients must demonstrate airway constriction brought on by exercise.
Exclusion Criteria:
- Patient is taking any medications that are not allowed in the study.
Locations and Contacts
Merck Sharp & Dohme IDEA, Inc., Zagreb 10 010, Croatia; Recruiting
Goranka Glad Scherr, Phone: 385 1 66 44 336
Vianex, S.A. / MSD, Nea Erythrea 146 71, Greece; Recruiting
Fotini Vlasserou, Phone: 30-210-8009435
Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728
Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825
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: January 2006
Last updated: October 15, 2008
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