A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476; montelukast sodium (Drug); Comparator: placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
A 53-week study to determine the effect of montelukast sodium when given to children (with
infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).
Secondary outcome: Parent/caregiver QOL endpoints.The safety and tolerability of montelukast when use as an episode modifier. The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.
Eligibility
Minimum age: 2 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females between the ages of 2 and 14 who have infrequent episodic asthma.
Locations and Contacts
Additional Information
Related publications: Robertson CF, Price D, Henry R, Mellis C, Glasgow N, Fitzgerald D, Lee AJ, Turner J, Sant M. Short-course montelukast for intermittent asthma in children: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Feb 15;175(4):323-9. Epub 2006 Nov 16.
Starting date: June 2000
Last updated: May 17, 2007
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