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[Exercise-induced asthma in children and oral terbutaline. A dose-response relationship study]
B Hertz1, G Fuglsang, E B Holm
1Børneafdelingen, Viborg Sygehus.
Insights
This study found that continuous oral terbutaline sulfate did not significantly protect against exercise-induced asthma in children. High doses did not improve asthma symptoms or prevent exercise-induced bronchoconstriction.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Respiratory Medicine
Background:
- Exercise-induced asthma (EIA) is a common condition in children.
- Asthma management often involves bronchodilators, but their efficacy in preventing EIA with continuous oral use requires further investigation.
Purpose of the Study:
- To evaluate the protective effects of increasing doses of a sustained-release terbutaline sulfate formulation on exercise-induced asthma.
- To assess the clinical efficacy and safety of this new formulation in pediatric asthma patients.
Main Methods:
- A randomized, double-blind, cross-over study involving 17 children (6-12 years) with asthma.
- Participants received placebo or increasing doses of terbutaline sulfate (4, 8, 12 mg/day) b.i.d. for 14 days.
- Exercise tests were conducted, and lung function (FEV1, PEF) and plasma terbutaline levels were measured.
Main Results:
- No significant improvement in home-monitored asthma symptoms or protection against exercise-induced asthma was observed compared to placebo.
- Percentage fall in FEV1 post-exercise showed no significant benefit with terbutaline treatment.
- A small, dose-related increase in morning and evening peak expiratory flow (PEF) was noted.
Conclusions:
- Continuous oral terbutaline sulfate treatment, even at high doses, does not provide clinically significant protection against exercise-induced asthma in children.
- The sustained-release formulation did not demonstrate efficacy in preventing exercise-induced bronchoconstriction.
Abstract:
We wanted to assess the protective effects on exercise-induced asthma as well as the clinical efficacy and safety of increasing doses of a new sustained-release formulation of terbutaline sulphate in 17 asthmatic children aged 6-12 years (mean 9 years). Placebo, 2, 4, and 6 mg terbutaline were given b.i.d. for 14 days in a randomized, double-blind, cross-over design. At the end of each two week period, an exercise test was performed and plasma terbutaline was measured. Compared with placebo, no significant effect was seen on asthma symptoms monitored at home, or on exercise-induced asthma. The percentage falls in FEV1 after the exercise test were 36, 35, 27 and 28%, after placebo, 4, 8 and 12 mg terbutaline/day, respectively. A small but statistically significant dose-related increase was seen in morning and evening peak expiratory flow (PEF) recordings. It is concluded that continuous treatment, even with high doses or oral terbutaline, does not offer clinically useful protection against exercise-induced asthma.