COPD or “chronic obstructive pulmonary disease” is a disease common to smokers who have damaged their lungs from years of tobacco use. Once COPD takes hold, there are often difficulties in getting around without shortness of breath, difficulty breathing at rest, chronic cough, and increased sputum production.
Recently, Boehringer Ingelheim announced the completion of two studies on a product called STIOLTO RESPIMAT, a combination inhaled medication for the treatment of COPD patients. The product, given as a propellant-free inhaler is a combination of the medication in Spiriva (tiotropium) and another long-acting bronchodilator (olodaterol) and was tested on 1,600 COPD patients and compared in a double-blind study against a placebo or against just Spiriva alone.
The results showed that patients who took STIOLTO RESPIMAT responded the best after 12 weeks of using the product. They reported less shortness of breath and an increase in quality of life when compared to taking Spiriva alone or a placebo. COPD patients often have trouble with the simple activities in life and it was found that by taking the STIOLTO RESPIMAT inhaler, patients were better able to do things like climb stairs without shortness of breath and go about daily activities.
Better yet, the side effects of STIOLTO RESPIMAT were found to be no different than taking Spiriva alone so that patients already taking Spiriva will be able to switch to the combination agent with the expectation of improved symptoms without any additional side effects.
STIOLTO RESPIMAT was approved by the FDA in May 2015, and helps COPD patients manage their condition with fewer negative symptoms. Because the inhaler contains potent and long-acting bronchodilators, they will not be used as rescue inhalers but as inhalers taken every day to control symptoms around the clock.
A phase III study is one that is done after the drug or drugs have been found to be safe and effective in small groups of people during phase I and phase II FDA trials. In phase III studies such as the two just announced, larger groups of COPD patients are given access to the drugs and their delivery system to further show positive actions of the drugs on COPD patients. Side effects continue to be tested in phase III studies, but the main focus is on effectiveness.
Researchers hope that those who take STIOLTO RESPIMAT will have an overall better quality of life with an increase in respiratory energy and better breathing around the clock.