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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00213252
Other study ID # 1000007674
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated May 12, 2014
Start date September 2005
Est. completion date February 2008

Study information

Verified date May 2014
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone. Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Montelukast plus prednisolone
Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast
Prednisolone
Six daily doses of oral prednisolone

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
The Hospital for Sick Children Merck Frosst Canada Ltd.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Schuh S, Willan AR, Stephens D, Dick PT, Coates A. Can montelukast shorten prednisolone therapy in children with mild to moderate acute asthma? A randomized controlled trial. J Pediatr. 2009 Dec;155(6):795-800. doi: 10.1016/j.jpeds.2009.06.008. Epub 2009 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic failure rate From randomization at discharge from the Emergency Department to day 8 No
Secondary Number of inhaled salbutamol treatments From randomization to 24, 48, 72, 96, 120, 144 hours and day 8 No
Secondary Change in the daytime asthma symptom scale from randomization 48 hours and Day 8 No
Secondary Change in the nighttime cough 8 days No
Secondary Number of days without asthma 8 days No
Secondary Change in the Pulmonary Index Score from baseline 48 hours and Day 8 No
Secondary Change in the Pediatric Respiratory Assessment Measure(PRAM)from baseline 48 hours and Day 8 No
Secondary Association between the main treatment effect and patients' age, disease severity at randomization (Pulmonary Index and PRAM) and personal/family history of atopy. 48 hours and Day 8 No
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