(HealthDay)—For patients with poorly controlled asthma, the addition of tiotropium to standard therapy is beneficial, according to a study published online Sept. 3 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the European Respiratory Society, held from Sept. 1 to 5 in Vienna.
Huib A.M. Kerstjens, M.D., from the University of Groningen in the Netherlands, and colleagues compared the effect of adding tiotropium or placebo delivered by soft-mist inhaler once a day for 48 weeks on lung function and exacerbations in two replicate randomized trials. The trials involved 912 patients with asthma (mean age, 53 years) who were receiving inhaled glucocorticoids and long-acting beta-agonists (LABAs). All participants were symptomatic and had a history of at least one severe exacerbation in the previous year.
The researchers found that the mean baseline forced expiratory volume in one second (FEV1) was 62 percent of the predicted value. In the two trials, the mean change in peak FEV1 was significantly greater with tiotropium than with placebo. In both trials, the pre-dose (trough) FEV1 also improved significantly with tiotropium compared with placebo. There was an increase in the time to first exacerbation with the addition of tiotropium (282 versus 226 days), and a significant overall reduction in the risk of severe exacerbation (hazard ratio, 0.79). Adverse events were similar between the groups and there were no deaths in either group.
"In patients with poorly controlled asthma despite use of inhaled glucocorticoids and LABAs, the addition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilation," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Boehringer Ingelheim and Pfizer, both of which funded the study and manufacture tiotropium.