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The addition of tiotropium bromide(136310-93-5) over 48 weeks was associated with a 21% reduction in the risk of a first severe acute exacerbation in the third composite primary end point (HR 0.79, P = 0.03). Severe acute exacerbation is defined as the need to receive at least three days of systemic glucocorticoid therapy and decreased levels of lung function.

In addition, tiotropium bromide(136310-93-5) was associated with a 31% reduction in the risk of acute exacerbations of asthma (P <0.0001). Acute exacerbations were defined as a significant increase in symptoms or a 30% reduction in peak expiratory flow (PEF) 2 days. In one of the trials, the asthma control questionnaire (ACQ) and asthma-related quality of life questionnaire scores were also significantly improved, while in another trial an improvement in the asthma control questionnaire score was observed. The incidence of adverse events was similar in the tiotropium and placebo groups reported in these studies. The most frequently reported adverse events were nasopharyngitis and headache.

"The results of the first Phase III trial of the UniTinA-asthma ™ program are encouraging, and this will likely provide an opportunity for adult asthma," said Dr. Tunde Otulana, Ph.D., clinical development and medical affairs, Respiratory Drugs, Boehringer Ingelheim, "A new treatment option, with nearly half of asthma patients undergoing treatment, is still symptomatic of asthma, and even with acute asthma attacks, we will be evaluating the effects of tiotropium bromide(136310-93-5) in a wider range of asthma patients."

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