Boehringer Ingelheim today announced enrolment has commenced in its TOviTO Phase III clinical trial programme.
It will investigate tiotropium plus olodaterol in a once-daily fixed-dose combination for the treatment of chronic obstructive pulmonary disease (COPD).
Tiotropium, marketed under the brand name Spiriva® in COPD, is a long-acting muscarinic antagonist (LAMA) that provides 24-hour bronchodilation by blocking M 3 muscarinic receptors.
Tiotropium is the most prescribed COPD drug worldwide with more than 34 million patient years.
Olodaterol is a novel, once-daily, long-acting ß 2-agonist (LABA) that Boehringer Ingelheim has developed as an ideal partner to tiotropium in COPD.
Boehringer Ingelheim has decided to move the once-daily, fixed-dose combination of tiotropium plus olodaterol into the TOviTO Phase III trial programme on the back of promising olodaterol Phase III trial results, which will be published in the near future.
The TOviTO programme includes several trials that will provide important evidence to support olodaterol’s potential to improve patients’ lives beyond optimal bronchodilation.
The first two trials to begin in the comprehensive TOviTO programme will be TOnado 1 and its replicate study, TOnado 2.
TOnado 1 & 2 will be the first two pivotal studies to evaluate the safety and efficacy of the fixed-dose combination for the treatment of COPD patients, and are planned to involve 5000 patients (2500 each) at more than 500 trial sites in approximately 40 countries.
The trials are multi-centered, multi-national, randomised, double-blind, parallel group studies that will compare the efficacy and safety of tiotropium plus olodaterol in fixed-dose combination with that of both mono-compounds (tiotropium and olodaterol).
Both the fixed-dose combination and monotherapies will be administered once-daily, for 52 weeks, via Boehringer Ingelheim’s Respimat® Soft Mist™ Inhaler (SMI).
Respimat® SMI is a new generation inhaler that provides a unique slow moving and long-lasting soft mist that is easy to inhale and produces superior lung deposition.
Respimat® SMI is preferred by patients compared to other currently available inhalers.
“We hypothesise the combination of tiotropium plus olodaterol, in a single Respimat® Inhaler device, will provide superior efficacy compared with the once-daily mono compounds,” said Professor Roland Buhl, Head of the Pulmonary Department at the University of Mainz, Germany, and the Co-ordinating investigator for both trials.
“The addition of a LABA to tiotropium, a current COPD standard-of-care, could represent a significant advancement in COPD treatment.
“For the first time, patients would be able to receive their once-daily dose of tiotropium alongside a specifically selected LABA, all in the one, convenient inhaler.”
The trials’ primary endpoints will be bronchodilation – as measured by FEV 1a AUC 0-3hb response and trough FEV 1 response at 24 weeks – and health status (quality of life) – as measured by the Saint George’s Respiratory Questionnaire (SGRQ).