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Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT
Antonio Clavenna1, Marco Sequi, Massimo Cartabia
1Laboratory for Mother and Child Health, Department of Public Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri," Milan, Italy.
Insights
Nebulized beclomethasone did not prevent recurrent viral wheezing in young children. This inhaled steroid treatment also showed no benefit in reducing respiratory tract infection symptoms.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Viral wheezing is a common cause of respiratory distress in young children.
- Recurrent episodes can significantly impact a child's quality of life and healthcare utilization.
Purpose of the Study:
- To evaluate the efficacy of nebulized beclomethasone in preventing viral wheezing recurrence.
- To assess the impact of nebulized beclomethasone on respiratory tract infection symptoms.
Main Methods:
- Randomized, double-blind, placebo-controlled trial involving 525 children aged 1-5 years.
- Children received either beclomethasone (400 μg) or placebo via nebulizer twice daily for 10 days.
- Primary endpoint: incidence of viral wheezing diagnosed by pediatricians during treatment.
Main Results:
- No statistically significant difference in viral wheezing incidence between beclomethasone and placebo groups (9.0%).
- Parental assessment of treatment helpfulness was similar across groups (64% vs 61%).
- No differences observed in the resolution of respiratory tract infection symptoms.
Conclusions:
- Inhaled corticosteroids, specifically nebulized beclomethasone, are ineffective for preventing recurrent viral wheezing.
- Nebulized beclomethasone offers no additional benefit in alleviating symptoms of upper respiratory tract infections in this population.
Objective:
The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing.
Methods:
The study was designed as a randomized, double-blind, placebo-controlled trial. Outpatient children aged 1 to 5 years with at least 1 episode of viral wheezing in the last 12 months, presenting to any of 40 Italian pediatricians for an upper respiratory tract infection, were randomly allocated to receive beclomethasone 400 μg or placebo twice daily for 10 days. Medications were administered through a nebulizer. A clinical evaluation was performed by the pediatrician at the start and end of the treatment period. A subjective evaluation of symptoms and efficacy of treatment was performed by the parents. The primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the 10-day treatment period.
Results:
A total of 525 children were enrolled in the study, 521 of whom were visited at the end of the treatment period. Wheezing was diagnosed by the pediatricians in 47 children (9.0% [95% confidence interval: 6.7 to 11.3]), with no statistically significant differences between treatment groups (beclomethasone versus placebo relative risk: 0.61 [95% confidence interval: 0.35 to 1.08]).The treatment was considered helpful by 63% of parents (64% in the beclomethasone group vs 61% in the placebo group). In all, 46% of children still had infection symptoms at the end of the treatment period, with no differences between groups.
Conclusions:
The findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing. Moreover, no benefits were found in reducing symptoms of respiratory tract infections.
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