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.
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)
Additional data presented
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)
References
- Buhl R, Derom E, Ferguson G et al. Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat improves outcomes vs monocomponents in COPD in two 1-year studies. ERS 2014. Abstract number: 1895.
- Buhl, R, Abrahams R, Bjermer L et al. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two 1-year studies. ERS 2014. Abstract number 922. 2014.
- National Institute of Health and Care Excellence (NICE). Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update) [CG101]. Available at: http://www.nice.org.uk/guidance/CG101/. Last accessed: September 2014.
- Boehringer Ingelheim. Data on File: SPI14-02. 2013.
- Boehringer Ingelheim. Data on File: SPI13-02(b). 2013.
- Derom E, Westman J, Groenke L et al. The 24-hour lung function profile of once-daily tiotropium and olodaterol fixed-dose combination compared with placebo and monotherapies in chronic obstructive pulmonary disease. 2014. ATS abstract #A148; Thematic Poster Session: D44.
- Magnussen H, Chanez C, Dahl R et al. The impact of stepwise withdrawal of inhaled corticosteroids on exacerbations in COPD patients receiving dual bronchodilation: WISDOM study. ERS 2014 abstract number 1890.
