Boehringer Ingelheim recently announced new positive data on the Phase IIIb OTEMTO® 1 and 2 trials (NCT01964352 and NCT02006732) on Spiolto® Respimat® (tiotropium plus olodaterol) in patients with chronic obstructive pulmonary disease (COPD). The study was published in the journal Respiratory Medicine and is entitled “Tiotropium+olodaterol shows clinically meaningful improvements in quality of life.”
COPD is one of the most common lung diseases and a major cause of morbidity and mortality worldwide, and is the third leading cause of death in the United States. It is a progressive disease in which individuals develop serious problems breathing with obstruction of the airways, shortness of breath (dyspnea), cough and acute exacerbations. Smoking is considered to be the leading cause of COPD and the disease can seriously impact the patient’s physical capacity, well-being and social functioning. There is currently no cure for COPD, and improving the patient’s quality of life is the main goal in treatment strategies.
Spiolto® Respimat® is based on a combination of tiotropium and olodaterol, two potent, long-acting bronchodilators. The drugs are delivered through the Respimat inhaler, a propellant-free inhaler that actively delivers a slow-moving mist to help patients naturally inhale the medication. Spiolto® Respimat® has been approved for COPD treatment in several European countries, the United States, Canada and Australia.
The 12-week OTEMTO® 1 and 2 trials correspond to double-blind, parallel-group, placebo-controlled studies to assess the impact of tiotropium plus olodaterol on lung function and health-related quality of life in patients with moderate to severe COPD.
The OTEMTO® trials involved 1,600 COPD patients and showed that Spiolto® Respimat® induced a clinically meaningful improvement in dyspnea, breathlessness feeling in comparison to a placebo, and also improved lung function, dyspnea and quality of life in comparison to treatment with only tiotropium (Spiriva®). In terms of safety, Spiolto® Respimat® was found to have a similar safety profile to Spiriva® and the placebo.
“The improvement in quality of life provided by Spiolto® Respimat® in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life” concluded in a news release the lead investigator of the OTEMTO® trials Dr. Dave Singh from the University of Manchester. “For example, this could mean that patients are able to walk up stairs without stopping, go out to socialize with friends or find it easier to wash and dress. Essentially, the data show that patients feel much better.”