Boehringer Ingelheim Pharmaceuticals, Inc. recently announced new data from the pivotal Phase III TONADO™ 1&2 studies (NCT01431274 and NCT01431287), regarding the efficacy and safety of its investigational product tiotropium/olodaterol delivered via the RESPIMAT inhaler for chronic obstructive pulmonary disease (COPD) treatment. The data was presented at the American Thoracic Society (ATS) 2015 International Conference in Denver, May 15 to 20.
COPD is one of the most common lung diseases and a major cause of morbidity and mortality worldwide, being the third leading cause of death in the United States. It is a progressive disease in which individuals develop serious problems in breathing with obstruction of the airways, shortness of breath (dyspnea), cough and acute exacerbations. Smoking is considered to be the leading cause of COPD.
Tiotropium and olodaterol are two potent, long-acting bronchodilators delivered through the RESPIMAT inhaler, a propellant-free inhaler that actively delivers a slow-moving mist to help patients inhale the medication. The TONADO™ 1&2 studies are 52-week trials double-blinded with parallel-groups in which patients with moderate to very severe COPD were randomized to five different groups receiving: olodaterol 5 mcg, tiotropium 2.5 mcg or 5 mcg, tiotropium/olodaterol 2.5/5 mcg or 5/5 mcg. All drugs were delivered with the RESPIMAT inhaler. The TONADO studies are part of a larger Phase III clinical trial named TOviTO, involving more than 15,000 individuals with varying severities of COPD worldwide to evaluate tiotropium/olodaterol RESPIMAT.
“Because lung function can be substantially reduced by the time most COPD patients first see a physician, maintenance treatment should be considered at the time of diagnosis,” noted the study’s investigator Dr. Gary T. Ferguson in a press release. “In these analyses, we saw that tiotropium/olodaterol RESPIMAT demonstrated a statistically significant improvement in lung function compared to tiotropium and olodaterol alone for COPD patients across all stages of the disease (A-D).”
At the ATS Conference, Boehringer showed that tiotropium/olodaterol RESPIMAT 5/5 mcg was able to significantly improve the lung function of COPD patients in comparison to tiotropium RESPIMAT 5 mcg and olodaterol RESPIMAT 5 mcg alone. This result was observed independently of the patient’s disease severity and whether he/she had never been treated or was previously treated with maintenance bronchodilator therapy, including inhaled corticosteroids. The combination tiotropium/olodaterol RESPIMAT 5/5 mcg was found to have a safety profile similar to the one of the two components alone.
“Boehringer Ingelheim has had an unwavering commitment to the COPD community in the U.S. for more than 40 years,” noted the Vice President, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Danny McBryan. “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.”
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