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Published on: April 6, 2017
Inhibition of exercise-induced-asthma (EIA) by nedocromil sodium and sodium cromoglycate in children
E Novembre1, G F Frongia, G Veneruso
1Department of Pediatrics, Ospedale A. Meyer, Florence, Italy.
Insights
Both nedocromil sodium and sodium cromoglycate effectively prevent exercise-induced asthma in children. Nedocromil sodium showed slightly better efficacy than sodium cromoglycate, with no observed side effects for either medication.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Pharmacology
Background:
- Exercise-induced asthma (EIA) is a common condition in children, impacting their quality of life.
- Current treatments aim to prevent bronchoconstriction triggered by physical activity.
Purpose of the Study:
- To compare the efficacy of nedocromil sodium (Ned) and sodium cromoglycate (SCG) in preventing exercise-induced asthma in children.
- To evaluate the safety profile of both medications at the dosages used.
Main Methods:
- A double-blind, placebo-controlled trial involving 19 asthmatic children (aged 6-15 years).
- Participants underwent a treadmill exercise test before and 20 minutes after a single dose of Ned (4 mg), SCG (10 mg), or placebo.
- Key efficacy measures included forced expiratory volume in 1 second (FEV1), peak expiratory flow rate (PEFR), and forced expiratory flow rate between 25% and 75% of FVC (FEF 25-75).
Main Results:
- Both Ned and SCG demonstrated significantly better protection against exercise-induced bronchoconstriction compared to placebo.
- Ned showed a statistically significant reduction in FEV1 fall (11.0 +/- 12.4%) compared to placebo (26.1 +/- 14.9%, p < 0.01).
- SCG also showed a significant reduction in FEV1 fall (14.6 +/- 11.5%, p < 0.05) versus placebo. Nedocromil sodium exhibited a slightly superior overall performance and efficacy at specific time points.
- Complete protection was achieved in 14 patients with Ned, 9 with SCG, and 2 with placebo.
- No adverse events were reported for either active treatment group.
Conclusions:
- Nedocromil sodium and sodium cromoglycate are effective in preventing exercise-induced asthma in children.
- Nedocromil sodium demonstrated a trend towards superior efficacy compared to sodium cromoglycate at the tested dosages.
- Both medications are well-tolerated, suggesting a favorable safety profile for managing EIA in pediatric populations.
Abstract:
Nedocromil sodium (Ned) 4 mg, sodium cromoglycate (SCG) 10 mg, and placebo were compared for their efficacy in preventing exercise-induced asthma. Nineteen asthmatic children aged six to 15 years performed a treadmill exercise test before and 20' after a single dose of drug in a double-blind trial. Both active drugs performed significantly better than placebo; in fact the exercise challenge resulted in a mean maximum fall in FEV1 of 26.1 +/- 14.9% after placebo, but only of 14.6 +/- 11.5% after SCG (P < 0.05), and 11.0 +/- 12.4% after Ned (p < 0.01). Measurements of PEFR gave similar results, while the effect of treatment on FEF 25-75 was significant for Ned alone (p < 0.05). Direct comparison between Ned and SCG at different time points demonstrated significant differences in FEV1 at 1 min (p < 0.05) with a better overall performance of Ned. In individual patients, complete protection was provided in 9 patients with SCG, in 14 patients with Ned and in 2 with placebo. No side effects were observed. This study suggests that at the dosages used there are only slight differences between SCG and Ned activity in the prevention of exercise-induced asthma.
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