COPD patients treated with tiotropium using a Respimat mist inhaler experience results similar to patients who take the drug in its dry powder form, according to researchers. The study was published in the New England Journal of Medicine.
“This was a much-awaited study, because previous, smaller studies had raised the question of whether there was an increased risk of death with the newer tiotropium device,” said lead author Robert Wise, MD, professor of medicine at the Johns Hopkins University School of Medicine. “We needed a very large trial to answer the question.”
Wise and colleagues recruited more than 17,000 COPD patients at 1,200 sites in 50 countries. They evaluated the safety and efficacy of tiotropium Respimat at a once-daily dose of 2.5 ?g or 5 ?g, as compared with tiotropium HandiHaler at a once-daily dose of 18 ?g.
At the end of the randomized, double-blind, prospective trial Respimat was non-inferior to HandiHaler with respect to the risk of death and not superior to HandiHaler with respect to the risk of the first exacerbation. Causes of death and incidences of major cardiovascular adverse events were similar in the three groups.
The new Respimat inhaler is approved for use in Europe, but not in the United States. The traditional inhaler, known as a HandiHaler, uses a dry powder form of the drug and is widely used in the United States.