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A new spacer device for administration of inhaled salbutamol: use in elderly asthmatics
Donateo L, Gerardi R, Cantini L
Advances in Therapy 1996 Sep-Oct;13(5):292-300
clinical trial
3/10 [Eligibility criteria: No; Random allocation: No; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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*

This randomized, parallel-group study compared the use of a metered-dose inhaler (MDI) equipped with a new spacer device (Jet spacer) with that of a standard actuator in the administration of salbutamol (two puffs, 100 micrograms four times daily) to 36 elderly patients with moderate asthma and poor inhalation technique. After a 1-week run-in period, patients entered the 1-week study. Forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR) were measured at screening (both groups using the standard actuator) before and 30, 60, 120, and 240 minutes after administration; these measurements were repeated at the start and end of treatment (patients using the spacer or standard actuator). Ratings of efficacy and tolerability by investigators and of acceptability by patients were recorded at the end of treatment. Increases from baseline (from 0 to 240 minutes) in FEV1 and PEFR were comparable in the two groups at screening visit but proved higher (significantly for FEV1, p < 0.01) in the Jet group than in the standard-actuator group after both the first and last doses of the 7-day treatment period. the Jet group reported greater acceptability than the standard-actuator group. One patient in each group had tremors. The new spacer device is thus a valid alternative to the conventional actuator in patients with definitely or potentially poor hand-mouth coordination.

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