Use of Montelukast to Treat Children With Mild to Moderate Acute Asthma

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Merck Frosst Canada Ltd.
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Montelukast; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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