Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial.

Author(s): Kerstjens HA, Disse B, Schroder-Babo W, Bantje TA, Gahlemann M, Sigmund R, Engel M, van Noord JA

Affiliation(s): Department of Pulmonology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. h.a.m.kerstjens@long.umcg.nl

Publication date & source: 2011-08, J Allergy Clin Immunol., 128(2):308-14. Epub 2011 Jun 2.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Some patients with severe asthma remain symptomatic and obstructed despite maximal recommended treatment. Tiotropium, a long-acting inhaled anticholinergic agent, might be an effective bronchodilator in such patients. OBJECTIVE: We sought to compare the efficacy and safety of 2 doses of tiotropium (5 and 10 mug daily) administered through the Respimat inhaler with placebo as add-on therapy in patients with uncontrolled severe asthma (Asthma Control Questionnaire score, >/= 1.5; postbronchodilator FEV, </= 80% of predicted value) despite maintenance treatment with at least a high-dose inhaled corticosteroid plus a long-acting beta-agonist. METHODS: This was a randomized, double-blind, crossover study with three 8-week treatment periods. The primary end point was peak FEV at the end of each treatment period. RESULTS: Of 107 randomized patients (54% female patients; mean, 55 years of age; postbronchodilator FEV, 65% of predicted value), 100 completed all periods. Peak FEV was significantly higher with 5 mug (difference, 139 mL; 95% CI, 96-181 mL) and 10 mug (difference, 170 mL; 95% CI, 128-213 mL) of tiotropium than with placebo (both P < .0001). There was no significant difference between the active doses. Trough FEV at the end of the dosing interval was higher with tiotropium (5 mug: 86 mL [95% CI, 41-132 mL]; 10 mug: 113 mL [95% CI, 67-159 mL]; both P < .0004). Daily home peak expiratory flow measurements were higher with both tiotropium doses. There were no significant differences in asthma-related health status or symptoms. Adverse events were balanced across groups except for dry mouth, which was more common on 10 mug of tiotropium. CONCLUSION: The addition of once-daily tiotropium to asthma treatment, including a high-dose inhaled corticosteroid plus a long-acting beta-agonist, significantly improves lung function over 24 hours in patients with inadequately controlled, severe, persistent asthma. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.