Fixed-dose combination shows improved lung function in COPD patients: Study

The fixed-dose combination of tiotropium and olodaterol (T+O FDC) has the potential to become a viable once-daily chronic obstructive pulmonary disease (COPD) treatment, according to data presented at the 2014 American Thoracic Society (ATS) International Conference, in San Diego.

Results of the VIVACITO study, the first phase 3 data to be reported from the TOviTO clinical trial program, evaluated the effect of T+O FDC delivered via the Respimat inhaler on lung function in people with COPD. The data were presented by Boehringer Ingelheim.

VIVACITO investigated the 24-hour bronchodilator profile of 2 T+O FDC dose combinations over 6 weeks in 219 patients with COPD. The patients were randomly assigned to receive 4 of the following treatments for 6 weeks, each with a 3-week period of no treatment in between: (1) placebo; (2) olodaterol 5 μg; (3) tiotropium 2.5 μg or tiotropium 5 μg; (4) T+O FDC 2.5/5 μg or T+O FDC 5/5 μg.

The primary end point was improvement in lung function, as measured by forced expiratory volume in one second (FEV₁), over 24 hours after 6 weeks of treatment. Secondary end points included additional tests measuring breathing over 24 hours.

Both doses of T+O FDC studied (2.25/5 μg, 5/5 μg) led to similar improvements in lung function over 24 hours as compared to placebo and monotherapies. 

“Despite advances made in recent years in the treatment of COPD, the need remains for additional therapies.” Said Tunde Otulana, MD, senior vice president, clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), combining bronchodilators with difference mechanisms of action may provide additional benefits for those living with COPD beyond what is seen with monotherapies alone, according to Dr Otulana.

As such, BI is developing the fixed-dose combination of tiotropium, a long-acting muscarinic antagonist (LAMA), and olodaterol, a long-acting beta2-agonist (LABA), in a phase 3 clinical trial program evaluating the efficacy and safety of the combination therapy in people with COPD.

“GOLD suggests combination treatment for patients uncontrolled on bronchodilator monotherapy to optimize symptom control,” said Dr Otulana.