A recent Johns Hopkins-led study involving authors rom the University of Texas Health Science Center and South Texas Veterans Health Care system compared the two drug-delivery systems, the new Respimat inhaler and HandiHaler, and showed almost the same effectiveness and safety in delivering a drug tiotropium in patients with chronic obstructive pulmonary disease (COPD).
Tiotropium is a long-acting inhaled brounchodilator that improves lung function in patients with COPD, a progressive lung disease that makes it difficult to breathe. There are two forms of COPD, emphysema and chronic bronchitis, and it is often caused by smoking and exposure to air pollution or chemical fumes. There is currently no cure for COPD but inhaled medications can delay the progression of the disease.
The new Respimat inhaler delivers the drug in a mist form and it is approved for use in Europe but not in the U.S. The traditional HandiHaler uses a dry powder form of the drug to deliver it and widely used in the U.S.
“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, says Robert Wise, M.D., professor of medicine at the Johns Hopkins University School of Medicine. “We needed a very large trial to answer the question.”
The study was a randomized, double-blind, prospective trial conducted at 1,200 sites in 50 countries with more than 17,000 COPD patients. The mean age of the patients was 65, and 71% of the patients were men. Researchers randomly made 3 groups of patients to examine the Respimat inhaler and the HandiHaler: a group for control, a group with a dose of 5 micrograms and a group with 2.5 micrograms.
“Our study found that the safety profile of tiotropium delivered with the Respimat system, in either a dose of 5 micrograms or 2.5 micrograms, was similar to the traditional dose of the drug that is in wide use today delivered with the HandiHaler. In other words, there was no significant difference in the incidence of major cardiovascular events or risk of death among the three groups studied,” Wise says.
The researchers also found that the risk of worsening of two or more major respiratory symptoms for at least three days, was not significantly different when comparing the two devices or the different doses of the drug.
Results of the study appeared in the New England Journal of Medicine on Sept. 8, 2013, and they were presented in the same day at the European Respiratory Society meeting in Barcelona, Spain.
Photos from http://www.respimat.com and http://www.pharmaceutical-technology.com