Boehringer Ingelheim Pharmaceuticals has presented new data analyses from two Phase 3 studies of its tiotropium/olodaterol Respimat SMI for the treatment of COPD at ATS 2015. The two efficacy and safety studies (NCT01431274 and NCT01431287), compared a fixed dose tiotropium/olodaterol combination delivered by the Respimat inhaler to each of the individual components delivered by Respimat.
According to BI, the posters presented at ATS showed that:
“- After 24 weeks of treatment, tiotropium/olodaterol Respimat 5/5 μg improved lung function, as measured by trough FEV1, compared to tiotropium Respimat 5 μg in patients who were untreated and previously treated with maintenance bronchodilator therapy (mean increase 76 mL and mean increase 48 mL, respectively)
– Tiotropium/olodaterol Respimat 5/5 μg provided statistically significant improvements in lung function, as measured by trough FEV1 and FEV1AUC0-3, compared to tiotropium Respimat 5 μg and olodaterol Respimat 5 μg alone in patients across all COPD stages
– Tiotropium/olodaterol Respimat 5/5 μg demonstrated statistically significant improvement of lung function over tiotropium Respimat 5 μg and olodaterol Respimat 5 μg irrespective of whether patients were taking inhaled corticosteroids (ICS) at the start of the trials
– Tiotropium/olodaterol Respimat 5/5 μg had a comparable safety profile to tiotropium Respimat 5 μg or olodaterol Respimat 5 μg alone”
Danny McBryan, Boehringer Ingelheim Pharmaceuticals, Inc. VP, Clinical Development & Medical Affairs, Respiratory, said, “Boehringer Ingelheim has had an unwavering commitment to the COPD community in the US for more than 40 years. We’re encouraged by these new data from the pivotal tiotropium/olodaterol Respimat trials and are working with regulatory authorities to bring this treatment to patients and their healthcare providers soon.”
The company submitted a marketing application to the EMA for the tiotropium/olodaterol Respimat product in July 2014 and submitted an NDA in the US in August 2014.
Read the Boehringer Ingelheim press release.
