A Phase 2 interventional study of Montelukast plus prednisolone and Prednisolone in Asthma, Bronchial, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
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.
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 mild to moderate acute asthma, with the Pulmonary Index score ≤ 11 points and PRAM ≤ 8 points. Asthma will be defined as at least the second episode of wheezing, with signs of lower airway obstruction. All participating children will receive a single dose of oral prednisolone 2mg/kg (max 60 mg) on arrival and standardized inhaled salbutamol in the ED and for five days thereafter. At discharge from ED children will be randomized to two interventional groups. Those in the Montelukast group will get oral Montelukast 4 mg (2-5 year olds), 5 mg (6-14 year olds), and 10 mg (15-17 year olds) as well as daily prednis(ol)one placebo 24 hours after the ED dose of prednisolone and at 48, 72, 96 and 120 hours, while those in the prednisolone group will receive Montelukast placebo and daily oral prednisolone 1mg/kg (max 60 mg) for five further doses at these times.
The primary outcome will be therapeutic failure in the two groups from randomization to day 8. This failure will be defined as unscheduled medical visits for asthma symptoms or hospitalization or treatment with oral corticosteroids outside the experimental protocol. Secondary outcome measures include comparison of the number of salbutamol treatments, changes in the previously validated daytime symptoms scale, nighttime cough/awakening scale, number of asthma-free days within the 8 day observational period in the two groups, changes in the PI and PRAM scores to 48 hours and day 8 as well as the association between the main treatment effect and age, pulmonary index at randomization and history of atopy.
This study will take two 9 months periods. Primary analysis will include a one-sided 95% CI for the difference in failure rate in the prednisolone group minus the Montelukast group. Secondary analyses will include repeated measures ANOVA for differences in changes of continuous variables and the Fisher's Exact test for comparison of proportions. An exploratory sub-group logistic regression analysis will be done for examining interaction between the main treatment effect and possible covariates.
In the event that the patients given a single dose of prednisolone followed by Montelukast have comparable therapeutic failure rate to those given standard extended prednisolone therapy, administration of Montelukast may help us abbreviate the length of corticosteroid therapy in children with acute asthma.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 130 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Drug: Montelukast plus prednisolone
Drug: Prednisolone
Single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast
Six daily doses of oral prednisolone
Therapeutic failure rate
Time frame: From randomization at discharge from the Emergency Department to day 8
Number of inhaled salbutamol treatments
Time frame: From randomization to 24, 48, 72, 96, 120, 144 hours and day 8
Change in the daytime asthma symptom scale from randomization
Time frame: 48 hours and Day 8
Change in the nighttime cough
Time frame: 8 days
Number of days without asthma
Time frame: 8 days
Change in the Pulmonary Index Score from baseline
Time frame: 48 hours and Day 8
Change in the Pediatric Respiratory Assessment Measure(PRAM)from baseline
Time frame: 48 hours and Day 8
Association between the main treatment effect and patients' age, disease severity at randomization (Pulmonary Index and PRAM) and personal/family history of atopy.
Time frame: 48 hours and Day 8
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children