Date: 2012-05-22
Type of information:
phase: 2
Announcement: results
Company: Boehringer Ingelheim (Germany)
Product: tiotropium
Action mechanism:
Disease: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details: 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).
Latest
news: Boehringer Ingelheim announced 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). 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. 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. Boehringer Ingelheim also 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. This comprehensive Phase III trial program includes a number of clinical trials in adults, adolescents and pediatric patients across different asthma severities who remain symptomatic/uncontrolled on current treatment with inhaled corticosteroids. The program includes over 4,000 patients in more than 150 sites globally.
