Boehringer Ingelheim presented the first data from the pivotal Phase 3 TONADO 1&2 studies (NCT01431274/NCT01431287) for the fixed-dose combination (FDC) of tiotropium plus olodaterol delivered via the Respimat inhaler in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The data were presented at the European Respiratory Society (ERS) International Congress 2014 in Munich.
Once-daily tiotropium + olodaterol FDC is an investigational combination that includes the long-acting muscarinic antagonist (LAMA) tiotropium with olodaterol, a long-acting beta agonist (LABA), delivered via the propellant-free Respimat inhaler, which generates a slow-moving mist.
The pivotal 52-week TONADO 1&2 studies included more than 5,500 patients with COPD. Results showed that lung function, as measured by trough forced expiratory volume in one second (FEV(1)), improved in patients receiving tiotropium + olodaterol FDC delivered via the Respimat inhaler, and that St. George’s Respiratory Questionnaire (SGRQ) total score was affected favorably compared to those receiving olodaterol or tiotropium alone.
“The results from the TONADO studies showed that the combination has the potential to improve lung function compared to the individual components alone in people with COPD,” said Gary Ferguson, Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan. “Approximately 15 million Americans have been told by a healthcare provider they have COPD, and this drug combination provides a potential new maintenance treatment option for people with COPD.”
TONADO 1&2 were 52-week, double-blind, parallel-group studies in which patients with moderate to very severe COPD were randomized to receive olodaterol 5 mcg, tiotropium 2.5 mcg, tiotropium 5 mcg, tiotropium + olodaterol FDC 2.5/5 mcg or tiotropium + olodaterol FDC 5/5 mcg. Primary efficacy endpoints were change from baseline in trough FEV(1), FEV(1) area under the curve from zero to three hours and SGRQ total score after 24 weeks. These studies are part of a large Phase 3 clinical trial program (TOviTO) for tiotropium + olodaterol FDC, which includes more than 7,000 people with varying severities of COPD worldwide.
In a combined analysis presented at ERS, tiotropium + olodaterol FDC (5/5 mcg) resulted in statistically significant improvements in lung function compared to the individual components (P < 0.001 for each study). The improvement in total SGRQ score for patients treated with tiotropium + olodaterol FDC 5/5 mcg as compared to those receiving olodaterol 5 mcg and tiotropium 5 mcg separately was also statistically significant (P < 0.05 in both cases), but not clinically meaningful.
Date: September 8, 2014
Source: Boehringer Ingelheim