Phase III Data Reported for Tiotropium in Symptomatic Asthma Patients
Drug significantly improved lung function versus placebo (Sept. 3)
On August 3, Boehringer Ingelheim announced the first data from the phase III UniTinA-asthma program. In two studies, presented at the 2012 European Respiratory Society (ERS) Congress in Vienna, Austria, tiotropium delivered once daily via the Respimat inhaler significantly improved lung function and reduced asthma exacerbations in patients who remained symptomatic on current treatment with at least high-dose inhaled corticosteroids (ICSs) and long-acting beta agonists (LABAs). The data were simultaneously published online in the New England Journal of Medicine.
The two PrimoTinA-asthma studies were replicate double-blind parallel-group trials that included asthma patients with post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 80% predicted and an asthma control questionnaire score of 1.5 or greater while on at least high-dose ICS/LABA. A total of 912 patients were randomized to receive tiotropium 5 mcg or placebo in addition to usual care for 48 weeks. The co-primary lung-function endpoints included peak and trough FEV1 at 24 weeks.
Adding tiotropium provided significant improvements in lung function. In trial 1, the mean changes from baseline in peak and trough FEV1 for tiotropium versus placebo were 86 mL (P = 0.01) and 88 mL (P = 0.01), respectively. In trial 2, the mean changes from baseline in peak and trough FEV1 for tiotropium versus placebo were 154 mL (P < 0.001) and 111 mL (P < 0.001). These changes were sustained over 48 weeks.
In the combined analysis of the two trials, the addition of tiotropium was associated with a 21% risk reduction (hazard ratio: 0.79; P = 0.03) in the time to the first severe exacerbation at 48 weeks. Severe exacerbations were defined as a decrease in lung function requiring treatment with systemic corticosteroids for at least 3 days.
The addition of tiotropium also reduced the risk of an asthma exacerbation by 31% (P < 0.0001).
In these studies, the rates of adverse events reported in the tiotropium add-on and placebo add-on groups were similar. The most commonly reported adverse events were nasopharyngitis and headache.
For more information, visit the Boehringer Ingelheim Web site.