Results from Boehringer Ingelheim’s Respimat Phase II study on moderate, persistent asthma

Boehringer Ingelheim announced today results from a Phase II study evaluating the investigational compound tiotropium delivered once-daily via the Respimat^® Inhaler in adolescents with symptomatic, moderate persistent asthma. The data were presented at the 2012 Annual Meeting of the American Thoracic Society (ATS 2012). Boehringer Ingelheim announced that a comprehensive confirmatory Phase III trial program named UniTinA-asthma™ is ongoing to fully evaluate the potential of the long-acting bronchodilator in the treatment of asthma in pediatric, adolescent and adult patients. 

The results are from a Phase II, 4-week, randomized, double-blind, placebo-controlled, incomplete cross-over study. This dose-ranging study evaluated 105 patients 12 to 17 years of age with moderate, persistent asthma on medium dose inhaled corticosteroids (ICS) with or without long-acting beta-agonist (LABA) or leukotriene receptor antagonists (LTRA). 

With all dosages of tiotropium administered once daily, lung function was greater as evaluated by peak FEV_1(0-3h) (1.25 microgram = 0.566 L; 2.5 microgram = 0.546 L; 5 microgram = 0.602 L), 1.25FEV_1AUC(0-3h) (1.25 microgram = 0.455 L; 2.5 microgram = 0.434 L; 5 microgram = 0.497 L) and trough FEV₁ (1.25 microgram = 0.384 L; 2.5 microgram = 0.353 L; 5 microgram = 0.442 L) compared to placebo (0.489 L, 0.363 L, 0.292 L, respectively). A statistically significant increase in lung function was observed with 5 microgram tiotropium administered once daily (peak FEV_1(0-3h) = 0.113 L, p = 0.004; FEV_1AUC(0-3h) = 0.133 L, p<0.001; trough FEV₁ = 0.151 L, p<0.001). The 5 microgram dose was chosen for further studies of tiotropium in this patient population.

"Despite substantial advancements in the treatment of asthma and a wide range of available therapeutic options, a significant number of patients still remain symptomatic," said Dr. Christian Vogelberg, of University Children's Hospital, Dresden, Germany and lead author of the study. "As the first available data looking at tiotropium in adolescents with asthma, these results warrant further investigation into the utility of tiotropium when added to inhaled corticosteroids in this patient population."

The most commonly reported adverse events included nasopharyngitis and asthma. These results are consistent with the previous Phase II proof of concept studies demonstrating clinical activity of tiotropium in adult patients with asthma.

"We are encouraged by these Phase II trial results in moderate, persistent asthma as we continue our Phase III clinical trial program," said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "Our goal is to develop a treatment option for patients who still experience asthma symptoms on current therapy."