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Clinical Investigations: ASTHMA |

Serious Asthma Exacerbations in Asthmatics Treated With High-Dose Formoterol*

Marianne Mann; Badrul Chowdhury; Eugene Sullivan; Richard Nicklas; Raymond Anthracite; Robert J. Meyer
Author and Funding Information

*From the Division of Pulmonary and Allergy Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD.

Correspondence to: Marianne Mann, MD, Division of Pulmonary and Allergy Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Ln, Rockville, MD 20857; e-mail address: mannm@cder.fda.gov



Chest. 2003;124(1):70-74. doi:10.1378/chest.124.1.70
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Objective: To review three prospective, randomized, placebo-controlled, double-blind clinical studies of formoterol (Foradil Aerolizer; Novartis Pharmaceuticals; Basel, Switzerland) at dosages of 12 μg and 24 μg 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 μg 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 μg 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 μg 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 μg bid, had a serious asthma exacerbation compared to none of 176 placebo-treated patients.

Conclusion: Regular use of high-dose inhaled formoterol (24 μg bid) may be associated with more frequent serious asthma exacerbations.


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