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Serious asthma exacerbations in asthmatics treated with high-dose formoterol
Marianne Mann1, Badrul Chowdhury, Eugene Sullivan
1Division of Pulmonary and Allergy Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857, USA.
Objective:
To review three prospective, randomized, placebo-controlled, double-blind clinical studies of formoterol (Foradil Aerolizer; Novartis Pharmaceuticals; Basel, Switzerland) at dosages of 12 microg and 24 microg bid for the treatment of patients with asthma.
Data Sources:
Clinical studies submitted to the US Food and Drug Administration in support of the approval of Foradil Aerolizer for marketing in the United States.
Results:
More patients treated regularly with formoterol, 24 micro g bid, had a serious asthma exacerbation than did patients who had been treated with placebo. In the first study, 4 of 135 adult patients (3%) who had been treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to none of 136 placebo-treated patients. In the second study, 5 of 136 patients (3.7%) treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to 2 of 141 placebo-treated patients (1.4%). In the third study, 11 of 171 pediatric patients (6.4%) treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to none of 176 placebo-treated patients.
Conclusion:
Regular use of high-dose inhaled formoterol (24 microg bid) may be associated with more frequent serious asthma exacerbations.