Phase 3 data of VIVACITO study evaluating effect of T+O FDC in COPD presented at ATS conference

Boehringer IngelheimMay 22 2014

Boehringer Ingelheim today presented results of the VIVACITO^® (NCT01559116) study, the first Phase 3 data to be reported from the TOviTO^® clinical trial program, evaluating the effect of the fixed-dose combination of tiotropium and olodaterol (T+O FDC) delivered via the Respimat^® inhaler on lung function in people with chronic obstructive pulmonary disease (COPD). These data were presented as a late-breaking poster at the American Thoracic Society (ATS) 2014 International Conference.

Once-daily T+O FDC is an investigational treatment that combines the long-acting muscarinic antagonist (LAMA) tiotropium with olodaterol, an investigational long-acting beta agonist (LABA), delivered via the Respimat^® inhaler, a propellant-free inhaler that generates a soft, slow-moving mist. The Phase 3 clinical trial program for T+O FDC, TOviTO^®, is a large global program that includes more than 8,000 patients with COPD.

"The improvement in lung function seen in the VIVACITO^® study suggests that T+O FDC has the potential to become a viable once-daily COPD treatment," said Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf in Germany. "This is good news as we have learned that not all patients respond to just one therapy and more options are needed, particularly considering the incidence of COPD is projected to increase worldwide in the coming decades."

VIVACITO^® was a Phase 3 study in which 219 patients with moderate to very severe COPD were randomized to receive four of the following treatments for six weeks, each with a three-week period of no treatment in between: (1) placebo; (2) olodaterol 5 mcg; (3) tiotropium 2.5 mcg or tiotropium 5 mcg; (4) T+O FDC 2.5/5 mcg or T+O FDC 5/5 mcg. The primary endpoint was forced expiratory volume in one second (FEV₁), a measure of the amount of air exhaled in one second, over 24 hours after six weeks of treatment. Secondary endpoints included additional tests measuring breathing over 24 hours.

The 24-hour time profiles for both FDCs were very similar and showed improvements in lung function, as measured by FEV₁, compared with placebo and monotherapies over 24 hours. Both T+O FDCs were statistically significantly superior to placebo.

Additionally, trough FEV₁ was measured as a secondary endpoint. Results showed increases in lung function at the end of the 24-hour dosing interval for the two T+O FDCs versus placebo and monotherapies.

The overall incidence of adverse events (AEs) was comparable between treatment groups: 46.4 percent with placebo, 37.7 percent with olodaterol 5 mcg, 39.4 percent with tiotropium 2.5 mcg, 44.2 percent with tiotropium 5 mcg, 36.0 percent for the T+O FDC 2.5/5 mcg, and 37.4 percent with T+O FDC 5/5 mcg. The most common individual AEs were nasopharyngitis and worsening of COPD.

"As a leading provider of COPD treatment for the last decade, we are excited by these first data from TOviTO^®, our extensive clinical trial program for the tiotropium plus olodaterol fixed-dose combination, and look forward to presenting additional trial results later this year," said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Today, Boehringer Ingelheim has a diverse respiratory pipeline that includes several exciting developments for tiotropium." 

Results from the pivotal 52-week Phase 3 TONADO^® 1&2 trials, investigating the long-term effect of T+O FDC on lung function and quality of life in patients with COPD, are forthcoming.