RESUMO
OBJECTIVES: 1. To assess the clinical efficacy of drug delivery using paper spacer devices coupled to metered dose inhalers (MDI). 2. To compare the effectiveness of paper spacers with the standard volumatic spacer. DESIGN: Randomised double-blind placebo controlled clinical trial. SETTING: Asthma clinic of a family practice at Kalutara. PATIENTS: 134 patients over 12 years of age, who attended the clinic with an acute episode of wheezing. METHOD: All patients over 12 years of age with an acute episode of wheezing who could speak a sentence of over 5 words were randomly allocated into 4 groups and administered salbutamol inhalations through a MDI coupled to a spacer. The first group used a 6-inch paper spacer, second group an 8-inch paper spacer, the third group a 10-inch paper spacer and the fourth group used a standard 750 ml volumatic spacer. MEASUREMENTS: In each subject, the peak expiratory flow rate (PFR) was recorded at the start, after placebo inhalation and after salbutamol inhalation. An increase of PFR of over 20% from the basal value was assessed as a good response. RESULTS: The number of patients who showed a good response after salbutamol inhalations in all four groups were very significant compared with the responses after placebo inhalations (p < 0.001). No significant differences were found in the effectiveness of salbutamol among the four other groups (p > 0.1). CONCLUSIONS: 1. All devices show equal efficacy. Metered dose inhalers and all 3 paper devices are as effective as the standard volumatic spacer. 2. The cost of a paper spacer device is negligible compared to that of the volumatic spacer. 3. The use of paper spacers in Sri Lankan family practices makes inhaled MDI therapy much cheaper without decreasing the effectiveness of drug delivery.