Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD.
In COPD, the quality of life is measured by the SGRQ. A reduction equal to or greater than 4 points of the SGRQ score is considered clinically significant. I OTEMTO® trial results show that tiotropium / Olodaterol implies reduction of the SGRQ total score of 4.67 compared to placebo. Additional data collected in clinical trials OTEMTO, involving 1,600 patients, demonstrated that tiotropium / Olodaterol Respimat® determines:
- clinically meaningful improvements in breathlessness compared with placebo (improvement of 1.62 points in total score TDI), which translate into significant benefits in terms of quality of life;
- Dramatic improvements in lung function, breathlessness and quality of life compared to tiotropium;
- safety profile similar to monotherapy with tiotropium or placebo.
The incidence of adverse events (AE) was broadly comparable in different groups of patients, with a higher incidence of adverse events leading to discontinuation of treatment in the groups that were administered placebo than with tiotropium / Olodaterol.
Tiotropium / Olodaterol Respimat® has been approved in more than 20 countries in Europe, the United States, Canada and Australia for the treatment of patients with COPD. Tiotropium / Olodaterol Respimat was developed from tiotropium, boosted by Olodaterol, unique and effective beta2-agonist long-acting, acting quickly specifically developed as a drug can be associated with tiotropium. Tiotropium + Olodaterol is administered through the device Respimat, inhaler device, free of propellant gas, which delivers the active ingredient with a fine mist, which allows the drug to settle deep in the lungs, breathing naturally. Clinical studies OTEMTO® 1 & 2 are part of the Phase III program that TOviTO®, involving more than 15,000 patients, is one of the largest study programs ever conducted in COPD.