A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)(COMPLETED)
This study has been completed.
Information provided by:
First received: August 30, 2005
Last updated: May 24, 2013
Last verified: May 2013
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.
Drug: MK0476; montelukast sodium
Drug: Comparator: placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).
Secondary Outcome Measures:
- 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.
|Study Start Date:||June 2000|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
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