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 withformoterol, 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 withformoterol, 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.
RCT Entities:
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.
Authors: Karen E Wells; Edward L Peterson; Brian K Ahmedani; Richard K Severson; Julie Gleason-Comstock; L Keoki Williams Journal: J Allergy Clin Immunol Date: 2012-01-26 Impact factor: 10.793
Authors: Michael E Wechsler; Erik Lehman; Stephen C Lazarus; Robert F Lemanske; Homer A Boushey; Aaron Deykin; John V Fahy; Christine A Sorkness; Vernon M Chinchilli; Timothy J Craig; Emily DiMango; Monica Kraft; Frank Leone; Richard J Martin; Stephen P Peters; Stanley J Szefler; Wenlei Liu; Elliot Israel Journal: Am J Respir Crit Care Med Date: 2005-12-01 Impact factor: 21.405
Authors: Nicola A Hanania; Supria Singh; Rami El-Wali; Michael Flashner; Amie E Franklin; William J Garner; Burton F Dickey; Sergio Parra; Stephen Ruoss; Felix Shardonofsky; Brian J O'Connor; Clive Page; Richard A Bond Journal: Pulm Pharmacol Ther Date: 2007-07-17 Impact factor: 3.410