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Published on: November 4, 2010
A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma
Claudia R Morris1, Allan B Becker, Andres Piñieiro
1Department of Emergency Medicine, Children's Hospital & Research Center, Oakland, California 94609, USA. claudiamorris@comcast.net
Insights
Intravenous montelukast did not improve lung function or reduce hospitalizations in children with acute asthma. This study found no significant difference compared to placebo in emergency department treatment outcomes.
Area of Science:
- Pediatric Emergency Medicine
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Acute asthma necessitates emergency department visits for up to 30% of patients.
- Intravenous montelukast showed promise in adults with acute asthma, improving FEV1 and reducing hospital admissions.
- Standard emergency department therapy for acute asthma includes oxygen, albuterol, inhaled anticholinergics, and systemic corticosteroids.
Purpose of the Study:
- To assess the effectiveness of intravenous montelukast as an add-on therapy for acute asthma in children.
- To compare the efficacy of intravenous montelukast versus placebo in pediatric patients experiencing acute asthma exacerbations.
Main Methods:
- A randomized, double-blind, placebo-controlled, multicenter trial involving children aged 6 to 14 years.
- Patients with FEV1 ≤ 75% of predicted after standard therapy received either intravenous montelukast (5.25 mg) or placebo.
- Primary endpoint: time-weighted average change in FEV1 (deltaFEV1[0-60 min]); secondary endpoints: treatment failure rate and modified pulmonary index score.
Main Results:
- Intravenous montelukast did not demonstrate a significant improvement in deltaFEV1[0-60 min] compared to placebo (0.01 L difference; P = .78).
- No significant differences were observed in treatment failure rates or modified pulmonary index scores between the montelukast and placebo groups.
- Both intravenous montelukast and placebo were well-tolerated in the pediatric population studied.
Conclusions:
- Intravenous montelukast, when added to standard emergency department care, did not significantly improve FEV1 in children with acute asthma.
- The study concluded that intravenous montelukast offers no significant advantage over placebo for improving lung function, symptoms, or hospital course in pediatric acute asthma.
- Further research may be needed to explore alternative or adjunctive therapies for severe pediatric asthma exacerbations.
Background:
Up to 30% of patients require hospitalization for acute asthma despite standard therapy in the emergency department. In adults, intravenous montelukast added to standard therapy significantly improved forced expiratory volume in 1 second (FEV1) and reduced hospital admissions compared with standard therapy alone.
Objective:
To evaluate the efficacy of intravenous montelukast added to standard therapy in children with acute asthma.
Methods:
This was a randomized, double-blind, placebo-controlled, multicenter study of children aged 6 to 14 years conducted from August 25, 2005 to March 17, 2008. Patients with an FEV1 of 75% or less of the predicted value after up to 120 minutes of standard therapy (e.g., oxygen, albuterol, inhaled anticholinergics, and systemic oral corticosteroids) were randomized to intravenous montelukast, 5.25 mg (n=145), or placebo (n=131) added to standard therapy. The primary end point was the time-weighted average change in FEV1 during 60 minutes (deltaFEV1[0-60 min]). Secondary end points included the percentage of patients in whom treatment failed (patients who required hospitalization or for whom a decision to discharge was not reached within 2 hours after drug administration) and the change from baseline in modified pulmonary index score after 60 minutes of treatment.
Results:
Montelukast was not significantly more effective than placebo for deltaFEV1[0-60 min] when added to standard therapy (0.08 vs. 0.07 L; least squares mean, 0.01; 95% confidence interval, -0.06 to 0.08; P = .78). No significant differences were found in the percentages of patients in whom treatment failed or the modified pulmonary index score after 60 minutes. Both treatments were well tolerated.
Conclusions:
In this study of children with acute asthma, intravenous montelukast was not significantly better than placebo in improving FEV1, symptoms, or overall hospital course.
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