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A comparison of regular salmeterol vs 'as required' salbutamol therapy in asthmatic children
A von Berg1, J de Blic, M la Rosa
1Marien-Hospital, Wesel, Germany.
Insights
Regular salmeterol significantly improved lung function in children with asthma over 12 months. This long-acting beta-agonist treatment did not increase asthma exacerbations or airway hyperresponsiveness compared to placebo.
Area of Science:
- Pediatric Pulmonology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Asthma management in children requires effective long-term control.
- Long-acting beta-agonists (LABAs) like salmeterol offer potential benefits for asthma control.
- Assessing the efficacy and safety of LABAs in pediatric populations is crucial.
Purpose of the Study:
- To evaluate the efficacy of salmeterol 50 micrograms twice daily (b.i.d.) compared to placebo in improving lung function in children with asthma.
- To assess the impact of salmeterol on asthma exacerbation rates and bronchial reactivity.
- To determine the safety profile of regular salmeterol use in this age group.
Main Methods:
- A multicentre, double-blind, randomized, parallel study involving 426 asthmatic children aged 5-15 years.
- Patients received salmeterol 50 mcg b.i.d. or placebo b.i.d. for 12 months, with as-needed salbutamol for symptom relief.
- Lung function (PEF), exacerbation rates, and bronchial reactivity (PC20/PD20) were monitored throughout the study.
Main Results:
- Salmeterol treatment resulted in significant improvements in morning and evening peak expiratory flow rate (PEF) compared to placebo (P < 0.01; P < 0.05).
- No significant differences in asthma exacerbation rates were observed between the salmeterol and placebo groups.
- Salmeterol did not alter bronchial reactivity (PC20/PD20) during or after treatment cessation.
Conclusions:
- Regular salmeterol 50 mcg b.i.d. provides rapid, well-maintained lung function improvement in children with asthma over 12 months.
- Salmeterol therapy did not increase asthma exacerbation rates or bronchial hyperresponsiveness when used as adjunctive therapy.
- Salmeterol is an effective and safe treatment option for improving lung function in pediatric asthma patients.
Abstract:
In a multicentre, double-blind, randomized, parallel study, 426 asthmatic children aged 5-15 years old received salmeterol 50 micrograms b.i.d. or placebo b.i.d. via the Diskhaler. All patients had access to inhaled salbutamol to be used on an 'as required' (p.r.n.) basis for symptomatic relief. The study design comprised a 2-week baseline, a 12-month treatment period incorporating a 2-week 'off treatment' after 6 months, and a 2-week follow-up period at the end of the trial. At the end of 12 months of treatment with salmeterol, the adjusted change from baseline for morning and evening peak expiratory flow rate (PEF) was 56 and 47 l min-1, respectively, and this was significantly greater than placebo (P < 0.01; P < 0.05). Exacerbation rates did not differ between groups and results were not dependent upon concurrent inhaled steroid use. Neither treatment caused a change of > or = 1 doubling dose in PC20/PD20 either during or on stopping treatment. Treatment with regular salmeterol 50 micrograms b.i.d. over a 12-month treatment period provides a significant, rapid and well-maintained improvement in lung function without increasing bronchial reactivity or asthma exacerbation rates compared to p.r.n. salbutamol.