Boehringer Ingelheim has published new data from the two OTEMTO Phase 3b trials of the Stiolto/Spiolto Respimat tiotropium/olodaterol SMI for the treatment of COPD. The data show that the inhaler produced clinically meaningful improvements in quality of life versus placebo as measured by the St. George’s Respiratory Questionnaire (SRGQ).
The soft mist inhaler is marketed as Stiolto Respimat in the US, where it was approved by the FDA in May 2015, and as Spiolto Respimat in the European Union, where it was approved in July 2015.
The study, published online in the journal Respiratory Medicine, showed a 4.67 reduction in SGRQ score for Stiolto/Spiolto Respimat vs placebo. A reduction of 4 is considered clinically meaningful.
Lead investigator Dave Singh of the University of Manchester commented, “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. 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.”
Read the Boehringer Ingelheim press release.