Chest
Clinical InvestigationsAsthmaSerious Asthma Exacerbations in Asthmatics Treated With High-Dose Formoterol
Section snippets
Materials and Methods
Novartis Pharmaceuticals submitted data from clinical studies to support the use of orally inhaled formoterol (Foradil Aerolizer) twice daily for the long-term maintenance treatment of asthma. Three of the studies were placebo-controlled randomized clinical studies evaluating multiple doses of formoterol. Two of these trials have been reported in the literature.45
There were two 12-week, double-blind, randomized, placebo-controlled, parallel-group studies performed in patients 12 to 75 years of
Results
The two adult/adolescent studies randomized 541 patients and 554 patients. Each study showed that both formoterol doses were statistically significantly better than placebo for the primary end point of FEV1 measurement taken at the 12th hour posttreatment (ie, FEV1 at trough) at the week 12 visit. The pediatric study randomized 518 patients. In children, both formoterol doses were also statistically significantly better than placebo for the primary end point of FEV1 area under the curve
Discussion and Conclusions
The three clinical studies reported on herein demonstrated that twice daily formoterol (at a dose of either 12 μg or 24 μg) was statistically superior to placebo in terms of improving FEV1, which is an accepted end point for asthma control. The added benefit of formoterol, 24 μg bid, over formoterol, 12 μg bid, was considered to be marginal, and more patients who were randomized to receive formoterol, 24 μg bid, experienced serious asthma exacerbations compared to placebo, albuterol, 180 μg
ACKNOWLEDGMENT
The authors would thank Drs. Craig Ostroff, Virgil Whitehurst, and Laurence Sancilio for their helpful comments in preparing this manuscript.
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