Asthma and lower airway diseaseTiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma
Section snippets
Methods
Details of the methods, patients, and statistical analyses are provided in this article’s Online Repository at www.jacionline.org.
Results
Patients were enrolled in outpatient clinics between July 2006 and April 2008. Of 4225 patients screened for ADRB2 polymorphisms, 715 were B16-Arg/Arg positive, 530 were eligible for the trial, and 388 were randomized (Fig 2).
The most frequent reason for ineligibility was failure to meet the lung function inclusion criteria. Adherence to treatment was good (89% to 92%) and balanced between treatment groups; mean treatment exposure was comparable across groups (109.6-111.8 days). Demographic
Discussion
This study provides evidence that tiotropium administered once daily in the evening is not inferior to continued twice-daily salmeterol treatment in maintaining the lung function improvement achieved with salmeterol in B16-Arg/Arg asthmatic patients whose symptoms are not controlled by continued, stable, moderate-to-high doses of ICSs. By contrast, substitution of salmeterol by a placebo was associated with rapid deterioration in lung function (ie, both active treatments were superior to
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Supported by Boehringer Ingelheim and Pfizer.
Disclosure of potential conflict of interest: E. D. Bateman and L. M. Fabbri have consultant arrangements with, are lecturers for, are on the Advisory Board for, and receive research support from Boehringer Ingelheim and are lecturers and members of the Advisory Board for Pfizer. O. Kornmann has received research support from Boehringer Ingelheim. The rest of the authors have declared that they have no conflict of interest.