TONADO™ study shows further lung function and quality of life benefits with tiotropium + olodaterol Respimat® fixed dose combination in COPD

Data from the pivotal Phase III TONADO™ studies† for tiotropium + olodaterol Respimat® fixed dose combination (FDC) were presented for the first time at the European Respiratory Society (ERS) International Congress 2014 in Munich. The 52-week studies, involving more than 5,000 patients with Chronic Obstructive Pulmonary Disease (COPD), showed that tiotropium + olodaterol Respimat® FDC gave further lung function and quality of life benefits to patients, compared to either compound alone.¹

Data also showed that tiotropium + olodaterol Respimat® FDC was well tolerated with a favourable safety profile that was similar to tiotropium or olodaterol alone.² The TONADO™ results, together with the VIVACITO™ data presented earlier this year, formed a major part of the recent regulatory submissions in Europe for tiotropium + olodaterol Respimat® FDC in COPD.

COPD is a chronic disease that affects an estimated three million people in the UK.³ Currently tiotropium (Spiriva®) is the most prescribed COPD maintenance treatment worldwide, with a well-established efficacy and safety profile supported by data from more than 34 million patient years.^4;5 Olodaterol was specifically designed by Boehringer Ingelheim as a combination partner to tiotropium to provide added benefit for patients with COPD. Olodaterol monotherapy has received approval for the maintenance treatment of COPD in over 30 countries and is marketed under the brand name Striverdi® Respimat® in the UK.

"Spiriva® has been a cornerstone of maintenance therapy in COPD since its launch 12 years ago, providing benefit to millions of patients worldwide" said Dr. Charles de Wet, Medical Director, UK and Ireland at Boehringer Ingelheim. "It is important however that we continually strive to expand treatment options for patients, so we are delighted to present data illustrating additional lung function and quality of life benefits with tiotropium + olodaterol Respimat® fixed dose combination therapy."

The TONADO™ clinical trial

TONADO™ is part of the Phase III TOviTO™ clinical trial programme involving more than 8,000 patients. TOviTO™ is one of the largest trials to have been conducted in COPD to date.

Results from TONADO™ showed tiotropium + olodaterol Respimat® FDC provided a significant improvement in lung function and health-related quality of life over either monotherapy alone.¹ These data underpin the potential of tiotropium + olodaterol Respimat® FDC as a once-daily maintenance treatment option for patients with COPD.^1;6

Also presented at the ERS 2014 Congress were data from the 52-week WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) trial. This trial evaluated the effect of stepwise inhaled corticosteroid (ICS) withdrawal in patients with moderate to very severe COPD, who had a history of exacerbations and were being treated with triple therapy (LAMA+LABA/ICS). The aim was to investigate whether withdrawing the ICS and maintaining patients on LAMA+LABA therapy increased the risk of them having a COPD exacerbation compared to a group of identical patients who continued taking triple therapy.⁷

The results show that there was not a significant difference in time to first moderate or severe COPD exacerbation (on-treatment) in patients who had their ICS withdrawn, compared to patients who remained on triple therapy.

This result suggests that in patients with moderate to very severe COPD receiving dual bronchodilation therapy (LAMA+LABA), exacerbation risk is non-inferior following stepwise ICS withdrawal compared to patients on ICS.⁷

About tiotropium

Tiotropium (Spiriva®) is a long-acting muscarinic antagonist (LAMA) delivered via the HandiHaler® (18 mcg) or the Respimat® Soft Mist™ Inhaler (5 mcg). Tiotropium is licensed for the maintenance treatment of chronic obstructive pulmonary disease (COPD) symptoms and has comprehensive clinical trial data, demonstrating extensive experience since its introduction more than 12 years ago and over 34 million patient years of real life experience to support its efficacy and safety profile.⁵

About olodaterol

Olodaterol (Striverdi®) is a long-acting B2-agonist (LABA) delivered via the Respimat® Soft Mist™ Inhaler (5 mcg). Olodaterol is indicated as a maintenance bronchodilator treatment in patients with COPD.

Boehringer Ingelheim is developing olodaterol in combination with tiotropium with the aim of providing additional bronchodilation in the maintenance treatment of patients with COPD. Combining a LAMA and a LABA has the potential to deliver greater improvements in lung function and other outcomes, compared with individual drugs used alone.^8;9

About Respimat®

Respimat is a Soft Mist™ Inhaler (SMI); a delivery device which uses mechanical energy (a spring) to generate a long-lasting, slow-moving mist for inhalation.¹⁰