The first phase III data for the once-daily fixed-dose combination of Tiotropium and Olodaterol were presented at American Thoracic Society ( ATS ) 2014 International Congress.

Results from the Phase III VIVACITO study have shown that once-daily Tiotropium plus Olodaterol FDC have improved lung function ( FEV1 ) of COPD patients to levels significantly above those achieved with Tiotropium or Olodaterol monotherapies, or with placebo.
The 6-week trial with an incomplete crossover design was conducted in patients with moderate to severe COPD.

Many COPD patients remain symptomatic despite current standard care and therefore are limited in their daily activities. New, innovative treatments are needed to help improve patients’ lung function and their quality of life. The increase of more than 200 ml in trough FEV1 seen in the VIVACITO study with Tiotropium plus Olodaterol FDC compared to placebo is significant.

Once-daily Tiotropium plus Olodaterol FDC is an investigational treatment that contains the well-established once-daily LAMA Tiotropium ( Spiriva ) combined with Olodaterol ( Striverdi ), the new once-daily and fast-acting LABA delivered by the Respimat SoftMist Inhaler.

The VIVACITO data have shown that Tiotropium plus Olodaterol FDC demonstrated clear and consistent improvements in lung function ( FEV1 ) over 24 hours compared with Tiotropium or Olodaterol in monotherapy, and placebo.
In the study, Tiotropium plus Olodaterol FDC was shown to have a safety profile similar to Tiotropium.

The results from VIVACITO are the first phase III data for Tiotropium plus Olodaterol FDC presented from the TOviTO programme, one of the largest phase III clinical trial programmes ever conducted in COPD.
In addition to evaluating the effects of the Tiotropium plus Olodaterol FDC on lung function, the TOviTO programme is also focused on the evaluation of other important clinical outcomes related to the daily life of patients with COPD.

Source: Boehringer-Ingelheim, 2014

XagenaMedicine2014