Phase III results for Spiolto Respimat (tiotropium/olodaterol) in COPD published in Respiratory Medicine- Boehringer Ingelheim
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. These data are published online in the journal Respiratory Medicine.
The OTEMTO trials show Spiolto Respimat provides a reduction in SGRQ total score of 4.67‡ versus placebo. Further data from the 1,600 patient trials show Spiolto Respimat provides clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal score), reflecting the meaningful quality of life benefits, and consistent improvements in lung function, breathlessness and quality of life compared to Spiriva (tiotropium).
Finally it shows a safety profile similar to Spiriva or placebo. Incidence of adverse events (AEs) was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups.
Comment: Spiolto Respimat is approved as Stiolto Respimat by the FDA.
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