The US Food and Drug Administration (FDA) approved SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). SPIRIVA HandiHaler, developed by Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Conn, is already FDA-approved as a once-daily maintenance treatment for breathing problems associated with COPD
Data from two clinical trials support the new indication: the UPLIFT (Understanding the Potential Long-term Impacts on Function with Tiotropium) study and a 6-month study conducted in the Veterans Affairs setting. Together the two studies involved nearly 8,000 people with COPD. While the UPLIFT trial did not meet its primary endpoint (slowing the rate of decline in lung function versus placebo), it provided relevant and important clinical information regarding the effect of SPIRIVA HandiHaler on COPD exacerbations.
“With today’s approval, SPIRIVA HandiHaler is now the first steroid-free maintenance treatment that has been shown to reduce COPD exacerbations,” said Christopher Corsico, MD, MPH, vice president, drug regulatory affairs, Boehringer. “We also are pleased that the product label will now include data from the landmark UPLIFT trial, which provides important information for physicians to consider when making treatment decisions.”