Boehringer Ingelheim has announced the publication of 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.

These data are published in the journal Respiratory Medicine.1 In COPDi, health-related quality of life is commonly measured using the St George's Respiratory Questionnaire (SGRQ), a disease-specific patient- reported instrument that evaluates symptoms including frequency and duration of cough, wheezing and breathlessness.

A reduction in SGRQ score of 4 points or more is deemed clinically meaningful.2 The OTEMTO® trials show Spiolto® Respimat® provides a reduction in SGRQ total score of 4.67ii versus 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," said Dave Singh, Professor of clinical pharmacology and respiratory medicine, University of Manchester and lead investigator of the OTEMTO® trials. "For example, this could mean that patients no longer take a long time to wash and dress, are able to walk up stairs without stopping or go out to socialise with friends. This level of improvement could make a real difference to the life of a patient with COPD."

Further data from the 1,600 patient OTEMTO trials show Spiolto® Respimat® provides:

  • clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal scoreiii), reflecting the meaningful quality of life benefits
  • consistent improvements in lung function, breathlessness and quality of life compared to Spiriva® (tiotropium)
  • a safety profile similar to Spiriva® or placebo

OTEMTO® 1&2 build on the pivotal phase III TONADO® trials that demonstrate Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and reduction in rescue medication use over Spiriva® Respimat® right from the initial stages when patients first need maintenance therapy.3 The trials are part of the >15,000 patient TOviTO® Phase III clinical trial programme, one of the largest trial programmes conducted in COPD.

About Spiolto® Respimat®

Spiolto® Respimat® has gained approval in over 15 EU countries, the US, Canada and Australia for use in the treatment of patients with COPD.

Spiolto® Respimat® is built on tiotropium, the active ingredient in Spiriva® - the world's most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities.4 It is enhanced by olodateroliv, an effective long-acting beta2-agonist with a fast onset of action, to complement the efficacy of Spiriva®. Spiolto® is delivered by Respimat®, the only inhaler available that activelyv delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.5-11