Boehringer Ingelheim Pharmaceuticals has reported data from the pivotal Phase III TONADO I and II trials (NCT01431274/NCT01431287) for the fixed-dose combination (FDC) of tiotropium, plus olodaterol to treat patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The once-daily tiotropium + olodaterol FDC is an investigational combination of the long-acting muscarinic antagonist (LAMA) tiotropium and olodaterol, a long-acting beta agonist (LABA) delivered via the Respimat inhaler.
More than 5,500 patients with COPD were involved in the 52-week double-blind, parallel-group TONADO trials.
Results showed that compared with those receiving olodaterol or tiotropium alone, patients who received tiotropium + olodaterol FDC have seen improvement in the lung function, as measured by trough forced expiratory volume in one second (FEV1).
Pulmonary Research Institute of Southeast Michigan director Gary Ferguson said: "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.
"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."
In these trials, patients with moderate to very severe COPD were given olodaterol 5mcg, tiotropium 2.5mcg, tiotropium 5mcg, tiotropium + olodaterol FDC 2.5/5mcg or tiotropium + olodaterol FDC 5/5 mcg.
Primary efficacy endpoints of the trials were change from baseline in trough FEV1, FEV1 area under the curve from zero to three hours and SGRQ total score after 24 weeks.
The trials are part of a large Phase III clinical trial programme (TOviTO) for tiotropium + olodaterol FDC, which includes more than 7,000 people with varying severities of COPD across the world.
Boehringer Ingelheim Pharmaceuticals Clinical Development and Medical Affairs senior vice-president Tunde Otulana said: "The TONADO results, together with the VIVACITO data presented at a major medical meeting earlier this year, formed the basis of the recent regulatory submission to the US Food & Drug Administration for tiotropium + olodaterol FDC delivered via the Respimat inhaler.
"We’re encouraged by these findings as we continue to investigate additional options for people living with COPD across different severities."
Image: A chest X-ray demonstrating severe chronic obstructive pulmonary disease (COPD). Photo: courtesy of James Heilman, MD.