Status:
COMPLETED
Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Merck Frosst Canada Ltd.
Conditions:
Asthma, Bronchial
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief 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 the...
Detailed Description
We plan a randomized double blind double-dummy trial of 190 previously healthy children 2-17 years of age presenting to the Emergency Department (ED) at the Hospital for Sick Children in Toronto with ...
Eligibility Criteria
Inclusion
- age 2-17 years
- Clinical diagnosis of mild to moderate asthma as a second wheezing episode associated with signs of respiratory distress suggesting lower airway obstruction such as tachypnea and/or use of accessory muscles of respiration.
- baseline Pulmonary Index Clinical Score (Appendix B) ≤ 11 out of 15 possible points as well as PRAM ≤ 8 out of 12 points.
- Presenting to the Sick Kids Emergency Department
- Children capable of FEV1 measurement will have FEV1 more than 60% of the predicted value
- male or female
- Willing and able to provide informed consent (or informed consent by parents)
Exclusion
- No previous history of wheezing or bronchodilator therapy. This population may eventually have diagnoses other than asthma or viral induced wheezing
- Patients who received more than a single dose of oral corticosteroids within 72 hours prior to arrival
- Patients receiving more than 500 mcg per day of fluticasone for more than 1 month or more than 250 mcg of fluticasone for more than 7 days prior to arrival
- Patients who have had more than 2 previous visits to the asthma clinic at SickKids
- Patients who received Montelukast within one week of arrival
- Critically ill patients requiring airway stabilization
- Patients with severe asthma, defined as PI 12 to 15 or PRAM 9 to 12.
- Co-existent co-morbidities such as chronic pulmonary disease and cardiac disease requiring pharmacotherapy, neurologic disease and immune disorders.
- Previous admission to ICU for asthma.
- More than 3 hospitalizations for asthma during the past 12 months.
- Contact with varicella within the previous 21 days.
- Insufficient command of the English language
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00213252
Start Date
September 1 2005
End Date
February 1 2008
Last Update
May 13 2014
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8