Data analysis of three trials, OTEMTO® 1 and 2 and ENERGITO®, provided new evidence that Spiolto® Respimat® (Boehringer Ingelheim) improves the quality of life for chronic obstructive pulmonary disease (COPD) patients in maintenance therapy, and it offers a greater overall patient well-being and lung function in comparison to commonly prescribed maintenance therapies, Spiriva® Respimat® and a LABA/ICS therapy. Results from the trials were recently presented at the European Respiratory Society (ERS) International Congress 2015.
OTEMTO® 1 and 2 and ENERGITO® are part of the TOviTO® Phase III clinical trial, which was designed to investigate the safety and efficacy profile of Spiolto® Respimat® (tiotropium plus olodaterol) in COPD. Spiolto® Respimat® has the same active ingredient as Spiriva® Respimat®, one of the most common therapies for maintenance COPD treatment, and is further enhanced with olodaterol, a fast action beta2-agonist and long-acting bronchodilator.
Results from OTEMTO® 1 and 2 demonstrated that Spiolto® Respimat® provided significant clinical improvements in patients with moderate COPD when compared to placebo administration. Furthermore, 52.8% of the patients treated with Spiolto® Respimat® had significant improvements in quality of life, while only 39.2% had an improvement after treatment with Spiriva® Respimat®.
Data from these trials, published in the journal Respiratory Medicine, had already shown increased improvements in lung function and decreased breathlessness after treatment with Spiolto® Respimat®, and a similar safety profile between drugs and the placebo. The study was entitled “Tiotropium+olodaterol shows clinically meaningful improvements in quality of life“. For more information on the study please read here.
Dave Singh, Professor of clinical pharmacology and respiratory medicine, University of Manchester, commented on the studies’ results in a press release, “When many patients are first diagnosed their condition is already declining rapidly. Doing as much as possible, early on, can give patients the best opportunity to maintain a good quality of life for longer. This sub-analysis shows that Spiolto® Respimat® could give patients this opportunity.”
The ENERGITO® trial compared lung function improvement in patients treated with Spiolto® Respimat® and LABA/ICS salmeterol/fluticasone propionate, a type of therapy using steroids that is associated with serious side-effects and is widely used in the clinic. Main results show a 42% lung function improvement with Spiolto® Respimat® when compared to the steroid-based treatment.
“ICS-containing therapies certainly have a role in the management of COPD but questions remain regarding when to use these treatments,” said Professor Kai-Michael Beeh, Insaf GmbH Institut für Atemwegs-forschung, Wiesbaden, Germany, commenting on the relevance of results from this study. “The ENERGITO® results further support the potential benefit of Spiolto® Respimat® as a COPD maintenance therapy and the notion that steroid-containing therapies may only be required in a population of patients with more severe stages of the disease and frequent exacerbations.”