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New Phase III data for tiotropium + olodaterol fixed-dose combination (FDC) in COPD patients

Results from the Phase III study VIVACITO™, presented at the American Thoracic Society (ATS) 2014 International Congress in San Diego, demonstrated that once-daily tiotropium 5mcg + olodaterol 5mcg FDC, delivered using the Respimat® Soft Mist™ Inhaler, significantly improved lung function over 24 hours (measured by the forced expiratory volume of air exhaled over one second, FEV1) in patients with chronic obstructive pulmonary disease (COPD), to levels significantly above those achieved with tiotropium or olodaterol monotherapies, or with placebo.[1]

Once-daily tiotropium + olodaterol FDC is an investigational treatment that contains the well-established, once-daily LAMA[2], tiotropium, combined with olodaterol, a new once-daily LABA[3], delivered via the Respimat® Soft Mist™ Inhaler.

Commenting on the results, Dr Richard Russell, Consultant Chest Physician, Wexham Park Hospital said, “Many patients with COPD continue to experience symptoms despite current treatment options, which can impair their ability to perform daily activities. New treatment options are needed to help control COPD symptoms better and improve quality of life. The significant improvement in lung function demonstrated by the fixed-dose combination of tiotropium + olodaterol in the VIVACITO study compared to both tiotropium monotherapy and placebo is encouraging and will come as welcome news to both physicians and patients looking for new and better ways to manage COPD.”

Additionally, tiotropium + olodaterol FDC was shown to have a similar safety and tolerability profile to tiotropium alone.[1]

The TOviTO™ clinical trial programme

Results from the VIVACITO™ study are the first to be presented from the Phase III TOviTO™ clinical trial programme, which comprises of more than 8,000 patients and is one of the largest Phase III clinical trial programmes to be conducted in COPD. TOviTO™ is investigating the effect of tiotropium + olodaterol FDC on lung function, exercise tolerance, quality of life and other parameters in COPD patients.

Further data from the Phase III TOviTO™ clinical trial programme are due to report later this year. This includes results from the 52-week Phase III TONADO™ 1&2 trials, investigating the effect of tiotropium + olodaterol FDC on lung function and quality of life in patients with COPD.

Charles De Wet, Medical Director UK and Ireland said, “Boehringer Ingelheim is dedicated to advancing respiratory research and improving patient outcomes. The development of olodaterol to partner tiotropium demonstrates the company’s commitment to build on the heritage of Spiriva Respimat for the treatment of COPD patients. We look forward to the results of the TONADO 1&2 trials in the coming months.”

Data from the Phase III TONADO™ 1&2 trials will form a major part of Boehringer Ingelheim’s submission to regulatory authorities to support the registration of tiotropium + olodaterol FDC in COPD.

Source

[1] Tiotropium + olodaterol FDC is an investigational treatment and not approved for clinical use. Its safety and efficacy have not yet been fully established.

[2] Long-acting muscarinic antagonist

[3] Long-acting beta2-agonist

Boehringer Ingelheim