Boehringer Ingelheim has announced submission of Marketing Authorisation Applications in 31 European countries for the once-daily fixed-dose combination of Tiotropium plus Olodaterol in the Respimat Soft Mist Inhaler as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease ( COPD ). These applications are based on data from the large phase III TOviTO clinical trial programme.

Tiotropium plus Olodaterol fixed-dose combination is an investigational treatment that contains the COPD maintenance therapy, Tiotropium ( Spiriva ), combined with Olodaterol ( Striverdi ), the new once-daily and fast-acting LABA, delivered by the Respimat Soft Mist Inhaler.

Tiotropium has been proven to consistently reduce the risk of COPD exacerbations, provide long-term improvement in quality of life for patients and has a favourable impact on survival.
Olodaterol was specifically designed as a combination partner to Tiotropium to provide added benefits for patients with COPD.

The efficacy and safety of the Tiotropium plus Olodaterol fixed-dose combination ( FDC ) are evaluated in the phase III TOviTO clinical trial programme. Involving more than 8,000 patients, TOviTO is one of the largest trial programmes ever conducted in COPD.
In addition to evaluating the effects of the Tiotropium plus Olodaterol FDC on lung function, TOviTO is also focused on the evaluation of other important clinical outcomes related to the daily life of patients with COPD including quality of life, breathlessness and ability to exercise.

In the 6-week VIVACITO study, the first study reported from the TOviTO programme, the Tiotropium plus Olodaterol FDC demonstrated clear and consistent improvements in lung function ( FEV1 ) over 24 hours compared with Tiotropium or Olodaterol monotherapies, and placebo. It was shown to have a safety profile similar to its single components.

Data from the pivotal 52-week phase III TONADO 1 and 2 trials formed the major part of the regulatory submission. The trials investigated the effect of the Tiotropium + olodaterol FDC on lung function and quality of life in patients with moderate to severe COPD. ( Xagena )

Source: Boehringer-Ingelheim, 2014

XagenaMedicine2014