Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy

BACKGROUNDSome patients with asthma have frequent exacerbations and persistent airflow obstruction despite treatment with inhaled glucocorticoids and long-acting beta-agonists (LABAs).METHODSIn two replicate, randomized, controlled trials involving 912 patients with asthma who were receiving inhaled glucocorticoids and LABAs, we compared the effect on lung function and exacerbations of adding tiotropium (a total dose of 5 mu g) or placebo, both delivered by a soft-mist inhaler once daily for 48 weeks. All the patients were symptomatic, had a post-bronchodilator forced expiratory volume in 1 second (FEV1) of 80% or less of the predicted value, and had a history of at least one severe exacerbation in the previous year.RESULTSThe patients had a mean baseline FEV1 of 62% of the predicted value; the mean age was 53 years. At 24 weeks, the mean (+/- SE) change in the peak FEV1 from baseline was greater with tiotropium than with placebo in the two trials: a difference of 86 +/- 34 ml in trial 1 (P=0.01) and 154 +/- 32 ml in trial 2 (PCONCLUSIONSIn patients with poorly controlled asthma despite the use of inhaled glucocorticoids and LABAs, the addition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilation. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov numbers, NCT00772538 and NCT00776984.)