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FDA Approves Tiotropium Bromide Inhalation Powder for Reducing COPD Exacerbation NEW YORK -- December 18, 2009 --The US Food and Drug Administration (FDA) has approved tiotropium bromide inhalation powder (SPIRIVA HandiHaler) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). “Exacerbations of COPD are serious events that can negatively impact the lives of patients,” said Donald P. Tashkin, MD, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California. “People with COPD now have a once-daily treatment option that not only helps them manage the debilitating symptoms of COPD, but also can help them reduce the chance of an exacerbation.” The new indication is supported by data from the Understanding the Potential Long-term Impacts on Function with Tiotropium (UPLIFT) study and a 6-month study conducted in the Veterans Affairs setting, which together involved nearly 8,000 people with COPD. While the UPLIFT trial did not meet its primary endpoint of slowing the rate of decline in lung function versus placebo, it provided relevant and important clinical information regarding the effect of the inhalation powder on COPD exacerbations. In this trial, COPD patients in both treatment groups were allowed to use all of their respiratory medications with the exception of inhaled anticholinergics in order to simulate a real-world environment. The clinical data demonstrated that powder formulation used in combination with the inhaler sustained improved lung function over 4 years when compared with placebo and reduced COPD exacerbations, even with the use of these medications. The most common side effects included upper respiratory tract infection, dry mouth, sinus infection, and sore throat. SOURCE: Pfizer and Boehringer Ingelheim E-mail this page to a friend or colleague! To print, use this version