Boehringer Ingelheim's once-daily bronchodilator olodaterol* successfully completes Phase II clinical trial program in COPD

INGELHEIM, Germany--Data presented today at the 2012 Annual Meeting of the American Thoracic Society completes the olodaterol monotherapy Phase II clinical trial program in patients with chronic obstructive pulmonary disease (COPD). This Phase II study compared the efficacy of once-daily versus twice-daily olodaterol, delivered via the Respimat® Soft Mist™ Inhaler (SMI) device.


Olodaterol is a once-daily, long-acting ß2-agonist (LABA) that Boehringer Ingelheim is designing and developing as a COPD maintenance treatment to partner with tiotropium. Olodaterol monotherapy and the fixed-dose combination (FDC) with tiotropium are being developed in the Respimat® SMI. Olodaterol's efficacy as a true once-daily bronchodilator was investigated in a large Phase II clinical trial program, which demonstrated a significant improvement in lung function for at least 24 hours in patients with COPD.1,2 The Phase III trials have also been completed and will be presented at future medical meetings.

The most recently presented Phase II randomised, double-blind, cross-over study demonstrated a statistically significant increase in the lung function parameter FEV1 for at least 24 hours with a once-daily (QD) 5 µg dose of olodaterol which was as pronounced as that observed with a QD 10 µg dose. Overall, the QD 5 µg dose of olodaterol offered a superior 24-hour profile to both the QD 10 µg and twice-daily 2 µg doses.3 These results were comparable to previous Phase II studies which demonstrated that all dosages of olodaterol provided significantly greater bronchodilation (FEV1) for at least 24 hours, compared to placebo.1,2 Olodaterol was well tolerated in all dosages tested, with no relationship of total daily dose to the overall incidence of adverse events.1,2,3

Professor Guy Joos, Head of the Department of Respiratory Diseases, at Ghent University Hospital, Belgium, and the co-ordinating investigator for the trial, said: "In this study, olodaterol was shown to be a true once-daily LABA providing 24-hour bronchodilation in COPD patients. It is promising to see that the strong efficacy results of the Phase II program were achieved with the comparably low QD 5µg dose and a favourable safety profile."

The future combination partner to olodaterol, tiotropium, is a long-acting anticholinergic drug (long-acting muscarinic antagonist/LAMA) that provides 24-hour bronchodilation.4 It is being marketed under the brand name Spiriva® in COPD. Spiriva® HandiHaler® is the most investigated and prescribed maintenance COPD drug worldwide.25

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, said: "Boehringer Ingelheim is committed to advancing respiratory research and treatment. Our ultimate goal is to provide physicians and patients with a very efficient once-daily LAMA/LABA fixed-dose combination through a proficient drug delivery system, the Respimat® Soft Mist™ Inhaler. We are leading the field in the endeavour to achieve this, being the company that brought tiotropium to patients worldwide."

Respimat® Soft Mist Inhaler (SMI) is a new generation inhaler that provides a unique, slow moving and long-lasting soft mist5,6 that is easy to inhale7 and produces superior lung deposition.8,9 Respimat® SMI is preferred by patients compared to other currently available inhalers.10,11,12

On the back of promising olodaterol data, Boehringer Ingelheim is currently studying the efficacy of a once-daily fixed-dose combination of tiotropium and olodaterol in the TOviTO Phase III trial program. The TOviTO program includes several trials that could provide important evidence to support the potential of tiotropium and olodaterol to improve patients' lives beyond optimal bronchodilation.