Comparison of salbutamol efficacy in children--via the metered-dose inhaler (MDI) with Volumatic spacer and via the dry powder inhaler, Easyhaler, with the nebulizer--in mild to moderate asthma exacerbation: a multicenter, randomized study.
Author(s): Direkwatanachai C, Teeratakulpisarn J, Suntornlohanakul S, Trakultivakorn M, Ngamphaiboon J, Wongpitoon N, Vangveeravong M
Affiliation(s): Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Thailand.
Publication date & source: 2011-03, Asian Pac J Allergy Immunol., 29(1):25-33.
Publication type: Clinical Trial; Comparative Study; Multicenter Study; Randomized Controlled Trial
BACKGROUND: Beta(2) agonist administered via a nebulizer is the standard treatment for acute asthma exacerbation. There are some limitations for the use of nebulization. We conducted a study to determine the efficacy of salbutamol administered via the pMDI with Volumatic spacer and the Easyhaler (DPI) compared to nebulization in mild to moderate asthma exacerbations in children. METHODS: A multicenter, randomized, controlled study was conducted in children between 5 and 18 years of age who presented at an emergency or outpatient department. They were randomized to receive either 6 puffs of salbutamol via the pMDI with Volumatic spacer, or via the Easyhaler, or 0.15 mg/kg of salbutamol nebulized via oxygen (or compressed air). The primary outcome was the clinical response which was assessed using the modified Wood's asthma score. The secondary outcomes were: hospitalization, asthma revisit within 3 days, systemic corticosteroid use and adverse events. The clinical score, oxygen saturation, PR, RR, BP and adverse events were recorded at time 0 (before treatment) and 20, 40 and 60 minutes after drug administration. RESULTS: There were no statistically significant differences in the clinical response between the three groups at the 1st, 2nd or 3rd dose or for the SpO(2) or the respiratory rate while the children in the Easyhaler group had significantly less tachycardia after the 2nd dose. No significant adverse events were noted among the three groups. CONCLUSIONS: Salbutamol administered via pMDI with Volumatic spacer or DPI (Easyhaler) are as effective as salbutamol given via a nebulizer in providing effective relief of mild to moderate severity acute asthma exacerbation in children between 5 and 18 years of age.