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Chest. 2003 Jul;124(1):70-4.

Serious asthma exacerbations in asthmatics treated with high-dose formoterol.

Author information

1
Division of Pulmonary and Allergy Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857, USA.

Abstract

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.

PMID:
12853504
DOI:
10.1378/chest.124.1.70
[Indexed for MEDLINE]

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