Date: 2011-09-21
Type of information:
phase: 3
Announcement: beginning of patient enrolment
Company: Boehringer Ingelheim (Germany)
Product: tiotropium plus olodaterol
Action mechanism: 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. 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.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country:
Trial
details: The TOviTO program 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 program 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).
Latest
news: Boehringer Ingelheim has announced enrolment has commenced in its TOviTO Phase III clinical trial program. It will investigate tiotropium plus olodaterol in a once-daily fixed-dose combination for the treatment of chronic obstructive pulmonary disease (COPD). Boehringer Ingelheim has decided to move the once-daily fixed-dose combination of tiotropium plus olodaterol into the TOviTO Phase III trial program on the back of promising olodaterol Phase III trial results, which will be published in the near future.
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).
