A double-blind crossover study was carried out to compare the effects of nedocromil sodium 4 mg and placebo on exercise-induced bronchoconstriction in 13 asthmatic children, the test treatments being given by pressurized aerosol using either the Auty-Altounyan (A-A) spacer device or the normal adapter. Treatment was given 15 minutes before exercise challenge. Marked differences were seen between the two treatments in favor of nedocromil sodium for percentage decreases in peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) (p < 0.05–0.01) from prechallenge values measured at each of six times after exercise and for area under the curve of changing lung function with time postchallenge (p < 0.05–0.01). The maximum percentage decreases in PEFR and FEV1 were reduced with nedocromil sodium, but the difference between treatments was not significant (p > 0.05). In addition, placebo treatment produced significant improvements compared with controls in several of the variables assessed (p < 0.05). No statistically significant differences were seen between the two devices. No unusual symptoms or adverse reactions were reported during the study.
Effects of nedocromil sodium pressurized aereosol on exercise challenge using a spacer device and a normal adapter
BONER, Attilio;PIACENTINI, Giorgio;Peroni, Diego;
1988-01-01
Abstract
A double-blind crossover study was carried out to compare the effects of nedocromil sodium 4 mg and placebo on exercise-induced bronchoconstriction in 13 asthmatic children, the test treatments being given by pressurized aerosol using either the Auty-Altounyan (A-A) spacer device or the normal adapter. Treatment was given 15 minutes before exercise challenge. Marked differences were seen between the two treatments in favor of nedocromil sodium for percentage decreases in peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) (p < 0.05–0.01) from prechallenge values measured at each of six times after exercise and for area under the curve of changing lung function with time postchallenge (p < 0.05–0.01). The maximum percentage decreases in PEFR and FEV1 were reduced with nedocromil sodium, but the difference between treatments was not significant (p > 0.05). In addition, placebo treatment produced significant improvements compared with controls in several of the variables assessed (p < 0.05). No statistically significant differences were seen between the two devices. No unusual symptoms or adverse reactions were reported during the study.
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