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Home-made spacers for bronchodilator therapy in children with acute asthma: a randomised trial
Zar HJ, Brown G, Donson H, Brathwaite N, Mann MD, Weinberg EG
Lancet 1999 Sep 18;354(9183):979-982
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: A metered-dose inhaler (MDI) with spacer is the best way to deliver bronchodilator therapy for treatment of acute asthma. In developing countries, commercially produced spacers are generally unavailable or too costly. We tested the efficacy of home-made spacers (500 mL plastic bottle, polystyrene cup) compared with a conventional spacer for delivery of a beta2 agonist via MDI for children with acute asthma. METHODS: We studied children aged 5 to 13 years with acute asthma, stratified into those with mild airways obstruction (peak expiratory flow (PEF) 60 to 79% of predicted value) or moderate to severe airways obstruction (PEF 20 to 59% of predicted value). A beta2 agonist (fenoterol hydrobromide) was given via MDI and one of four randomly assigned spacers (conventional spacer, sealed 500 mL plastic bottle, unsealed 500 mL bottle, 200 mL polystyrene cup). Clinical score, pulmonary function tests, and oximetry were recorded at baseline and 15 min after treatment. If a second bronchodilator treatment was needed, nebulised fenoterol was given and the assessment repeated 15 min later. Primary outcome measures were changes in clinical score and pulmonary function, and need for and response to nebulisation. FINDINGS: 88 children were eligible for study. In 44 children with moderate to severe airways obstruction, a cup gave significantly less bronchodilation (median increase in: forced expiratory volume in 1 s (FEV1) 0%; PEF 12%) compared with the conventional spacer (37%; 59%), sealed bottle (33%; 36%), or unsealed bottle (18%; 21%, p < 0.05 for difference between groups). Nebulisation was required by ten of 11 who had used a cup, nine of 11 who had used an unsealed bottle, eight of 11 who had used a sealed bottle, and only four of 11 who had used a conventional spacer. After nebulisation, improvement in FEV1 (15.5%) and PEF (26%) was more marked in children who had used a cup than in those who had used a conventional spacer (5.5% FEV1; 4% PEF), sealed bottle (3%; 0%), or unsealed bottle (7%; 9%). For 44 children with mild airways obstruction, response to bronchodilator was similar for all spacers and need for nebulisation was not associated with use of a particular spacer. INTERPRETATION: A conventional spacer and sealed 500 mL plastic bottle produced similar bronchodilation, an unsealed bottle gave intermediate improvement in lung function, and a polystyrene cup was least effective as a spacer for children with moderate to severe airways obstruction. Use of bottle spacers should be incorporated into guidelines for asthma management in developing countries.

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