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Boehringer Ingelheim Presents First Data for Tiotropium in Adolescents with Moderate Persistent Asthma
Date:5/22/2012

SAN FRANCISCO, May 22, 2012 /PRNewswire/ -- 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 FEV1(0-3h) (1.25 microgram = 0.566 L; 2.5 microgram = 0.546 L; 5 microgram = 0.602 L), 1.25FEV1AUC(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 FEV1(0-3h)  = 0.113 L, p = 0.004; FEV1AUC(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 optio
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SOURCE Boehringer Ingelheim
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