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Safety of formoterol in children and adolescents: experience from asthma clinical trials


Background The safety of long-acting β2 agonist (LABA) therapy in asthma remains controversial but no large scale analyses have been published of LABA safety in children.

Methods The frequency of asthma-related deaths and hospitalisations following formoterol use in children (4–11 years) and adolescents (12–17 years), compared with non-LABA treatment, was assessed in all AstraZeneca-sponsored, randomised, controlled, parallel-group trials (≥3 months) where formoterol was used as maintenance and/or as reliever therapy.

Results 11 849 children and adolescents under the age of 18 years from 41 trials were identified, 82% of whom used an inhaled corticosteroid (ICS) as concomitant medication. The number of asthma-related deaths (one 13-year-old boy among 7796 formoterol-treated patients, and none among 4053 non-LABA-treated patients) was too low to allow any between-group comparison. The frequency of patients with asthma-related hospitalisations was not different in formoterol-treated versus non-LABA-treated patients, either in children (1.16% (38/3263) vs 1.11% (24/2165)) or in adolescents (0.51% (23/4533) vs 0.85% (16/1888)). Asthma-related hospitalisations based on daily dose of formoterol were: (A) 4.5 or 9 µg: 1.9% (18/980); (B) 18 µg: 0.5% (14/2870); (C) 36 µg: 0% (0/67); and (D) variable dosing: 0.75% (29/3879). There was no difference between formoterol-treated and non-LABA-treated patients as regards ethnicity.

Conclusions Formoterol use in children and adolescents (4–17 years) with asthma in this large study where the majority are prescribed concomitant ICS is not associated with any increased risk of asthma-related hospitalisations. The results are not influenced by dose or ethnicity.

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