Boehringer Ingelheim presented today 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 (ICS) and long-acting beta agonists (LABA). This data was simultaneously published online in the New England Journal of Medicine.
The two PrimoTinA-asthma(TM) studies were replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV1 <80% predicted and asthma control questionnaire score >/= 1.5 while on at least high dose ICS/LABA. A total of 912 patients were randomized to receive tiotropium 5 microgram or placebo in addition to usual care for 48 weeks.
The pre-specified co-primary lung function endpoints included peak and trough FEV1 at 24 weeks. Adding tiotropium provided significant lung function improvements at 24 weeks (mean change from baseline tiotropium vs placebo (plus or minus standard error): peak FEV1 trial 1: 86 (plus or minus 34) mL>P<0.001); trough FEV1 trial 1: 88 (plus or minus 34) mL>P<0.001)), which were sustained over 48 weeks.
For the third co-primary endpoint, in the pre-specified combined analysis of the two trials, the addition of tiotropium was associated with a 21% risk reduction (HR 0.79, P=0.03) in time to first severe exacerbation at 48 weeks. Severe exacerbations were defined as requiring systemic corticosteroids for at least 3 days and a decrease in lung function.
The addition of tiotropium also reduced the risk of any asthma exacerbation by 31% (P<0.0001), defined by a significant increase in symptoms or peak expiratory flow (PEF) drop >/= 30% over >/= 2 days.
There were also improved scores observed in the asthma control questionnaire (ACQ) and the asthma quality of life questionnaire in one trial, and a trend towards improvement in the ACQ in the other study.
In these studies, the rate of adverse events reported in the tiotropium add-on and placebo add-on groups was similar. The most commonly reported adverse events were nasopharyngitis and headache.
"These first Phase III results from the UniTinA-asthma™ program are encouraging based on their potential to provide a new treatment option for adults with asthma, approximately half of whom remain symptomatic despite current treatment options and may be suffering from asthma exacerbations," said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to evaluating tiotropium in a wide range of asthma patients."
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