The US FDA has approved Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, according to Boehringer Ingelheim (BI). The drug is not indicated to treat asthma or acute deterioration of COPD, BI noted.
According to a company news announcement, the pivotal trials for Stiolto Respimat evaluated more than 5,000 COPD patients and showed it provides statistically significant improvements in lung function (trough FEV1 and FEV1 AUC0-3h) at 24 weeks versus tiotropium and olodaterol alone.
“Stiolto Respimat produced greater lung function improvements in terms of FEV1compared to tiotropium and olodaterol alone in patients with COPD across a range of disease severities (GOLD 2 to 4),” said Richard Casaburi, MD, PhD, professor and associate chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center. “As a clinician, I am pleased to have a new treatment option to offer my patients.”
The 52-week Phase III Tonado 1 & 2 trials were randomized, double-blind, active-controlled trials that compared Stiolto Respimat to tiotropium Respimat 5 mcg and olodaterol Respimat 5 mcg. Both trials were part of the Tovito clinical trial program involving more than 15,000 COPD patients worldwide. Stiolto Respimat showed a safety profile similar to tiotropium or olodaterol alone.
“A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD. While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will improve lung function,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals Inc.