Asthma and lower airway diseaseTiotropium improves lung function in patients with severe uncontrolled asthma: A randomized controlled trial
Section snippets
Trial design
This randomized, double-blind, placebo-controlled, crossover study with three 8–week treatment periods was conducted in accordance with the Declaration of Helsinki. All patients provided written informed consent for participation in the clinical trial. The trial was registered at www.clinicaltrials.gov (NCT00365560). After a 2-week run-in period, eligible patients were randomized and entered a 24–week, double-blind treatment period. Visits occurred at the start of the trial (screening), at
Results
Patients were enrolled between August 2006 and November 2007. Of 132 patients screened, 110 were eligible for the trial, 107 were randomized, and 100 completed all 3 treatment periods (Fig 1). The demographic characteristics of randomized patients at screening are summarized in Table I. Medication used before the screening visit comprised LABAs and ICSs (per inclusion criteria), rapidly acting β-agonists (77%), short-acting anticholinergics (21%; no long-acting anticholinergics were used),
Discussion
Tiotropium resulted in significant bronchodilatation in patients with severe asthma not adequately controlled by maximal treatment according to guidelines, including a combination of high-dose ICS plus LABA treatment. The bronchodilator effect was not different between the 2 doses and was not associated with significant improvement in any related outcome.
Although most patients with asthma can achieve control with appropriate medication according to the guidelines, some patients remain
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Supported by Boehringer Ingelheim and Pfizer.
Disclosure of potential conflict of interest: H. A. M. Kerstjens receives research support from Boehringer Ingelheim and Pfizer and has consulted with Boehringer Ingelheim. J. A. van Noord receives research support from Boehringer Ingelheim, Chiesi, Novartis, and GlaxoSmithKline. The rest of the authors have declared that they have no conflict of interest.