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Tiotropium improved asthma control as add-on therapy to ICS

Tiotropium used as an additional treatment to inhaled corticosteroids reduced airflow obstruction and improved control in patients with moderate asthma, according to recent study data.

“Our findings show that in patients with moderate asthma who are receiving medium-dose inhaled corticosteroids, addition of once-daily tiotropium significantly improves lung function and asthma control compared with placebo, and has similar efficacy and tolerability to salmeterol,” Huib A.M. Kerstjens, MD, of the University of Groningen in the Netherlands, and colleagues wrote.

The researchers conducted two 24-week, replicate, randomized, double blind, placebo-controlled trials at 233 sites across 14 countries, including the United States, from August 2010 to November 2012 to determine the safety and efficacy of tiotropium in patients with moderate asthma who experienced symptoms while maintaining therapy with inhaled corticosteroids (ICS). The ICS was equivalent to 400 µg to 800 µg budesonide.

Patients (n = 2,103) were randomly assigned once-daily tiotropium 5 µg (n = 519), 2.5 µg (n = 520), twice-daily salmeterol 50 µg (n = 541), or placebo (n = 523); 1,972 patients completed the study.

Compared with placebo, the difference in peak forced expiratory volume in 1 second (FEV₁) in pooled data was 185 mL (95% CI, 146-223) for tiotropium 5 µg, 223 mL (95% CI, 185-262) for tiotropium 2.5 µg and 196 mL (95% CI, 158-234) in the salmeterol group. Trough FEV₁ response for tiotropium 5 µg (146 mL; 95% CI, 105-188), tiotropium 2.5 µg (180; 95% CI, 138-221) and salmeterol (114; 95% CI, 73-155) was significantly greater than placebo.

Serious adverse events occurred in 2% of cases and were similar for all groups.

“Our data suggest that once-daily tiotropium is an effective controller treatment in patients with moderate asthma whose disease remains uncontrolled with inhaled corticosteroids alone, with efficacy similar to that of salmeterol,” the researchers wrote. “These findings potentially support the addition of a long-acting anticholinergic to inhaled corticosteroids in patients with moderate asthma.”

Disclosure: Kerstjens reports being principal investigator with grants to the University Medical Center Groningen and from Boehringer Ingelheim and Pfizer, along with serving on advisory boards for Boehringer Ingelheim and Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.