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Budesonide/formoterol versus salmeterol/fluticasone for asthma in children: an effectiveness and safety analysis
Ping Jiang1, Lanyu Zhao1, Zezhong Yao1
1Department of Pediatrics, Minhang Hospital, Fudan University, Shanghai 201100, China.
Insights
Budesonide + formoterol and salmeterol + fluticasone therapies showed similar efficacy in children with persistent asthma. Budesonide + formoterol offers advantages like lower steroid exposure and cost.
Area of Science:
- Pediatric Pulmonology
- Pharmacotherapy
- Asthma Management
Background:
- Limited comparative data exists for budesonide + formoterol versus high-dose salmeterol + fluticasone in pediatric asthma.
- This study addresses the efficacy and safety of these two treatment regimens in Chinese children.
Purpose of the Study:
- To compare budesonide + formoterol (twice daily + as needed) with salmeterol + fluticasone (twice daily + SABA as needed) in children with persistent asthma.
- To evaluate primary outcomes including time to first severe exacerbation and secondary outcomes such as hospitalization rates and asthma control.
Main Methods:
- A prospective cohort study involving 164 children (aged 12-17 years) with persistent asthma and a history of exacerbations.
- Participants were randomized into two groups receiving either budesonide + formoterol or salmeterol + fluticasone.
- The primary efficacy endpoint was the time to the first severe asthma exacerbation.
Main Results:
- No significant difference in the rate of asthma exacerbations per 100 patients per year was observed between the two groups.
- While the budesonide + formoterol group had fewer hospitalizations/ER visits, this difference was not statistically significant.
- Both treatment regimens demonstrated comparable effects on asthma control and were well-tolerated.
Conclusions:
- Budesonide + formoterol therapy is a favorable option for pediatric persistent asthma, offering a lower inhaled corticosteroid load and reduced steroid exposure.
- The combination therapy presents benefits in terms of requiring fewer inhalers and potentially lower costs.
- No significant differences in key outcome measures were found between the two treatment strategies.
Abstract:
Background: The efficacy of budesonide + formoterol therapy compared with high-dose salmeterol + fluticasone therapy plus short-acting β-agonist (SABA) has not been evaluated specifically in children. Objectives: To evaluate the efficacy and safety of budesonide + formoterol combination therapy two times a day plus as needed compared with salmeterol + fluticasone two times a day plus SABA (as needed) in children in China. Methods: This prospective cohort study included 164 children with persistent asthma (aged 12-17 years) who had experienced a minimum of one asthma exacerbation in 12 months prior to the study. The primary outcome was the time to the first severe exacerbation. Results: Eighty-two children were assigned to each of two groups. The exacerbation rate per 100 patients per year was not found to be significantly different. The number of patients with hospitalization/emergency room therapy was lower in budesonide + formoterol group, but the risk difference was not statistically significant. Asthma control measures showed comparable effects. Both treatments were well-tolerated. Conclusion: No significant differences were observed in the outcome measures between the groups. Budesonide + formoterol therapy is a favorable approach in terms of a low load of ICS, steroid exposure, need for multiple inhalers and cost.
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