GlaxoSmithKline and Theravance recently announced positive results of a Phase 3 trial that tested Incruse Ellipta as a combined treatment for chronic obstructive pulmonary disease (COPD).
The Phase 3 trial consisted of the two studies, which enrolled a total of 1,238 patients with COPD in a double-blind, placebo-controlled, multi center and randomized trial. The findings revealed that patients who underwent Incruse Ellipta treatment, in addition to Relvar/Breo Ellipta, saw a significant improvement in lung function compared to patients who took a placebo added to the inhaled corticosteroid/long-acting beta2-agonist combination.
“We are pleased with the positive data from these two studies evaluating an open triple therapy, Incruse added to Relvar/Breo Ellipta. With the data reported, we have further strengthened our understanding of Relvar/Breo Ellipta,” Rick Winningham, Theravance CEO, said.
The studies were the first to investigate the combined effect of two of the “newest medicines from [GlaxoSmithKline] respiratory portfolio” and both provided 24 hour efficacy. “We will continue to progress our research to expand our understanding of how the combined use of these medicines may provide physicians with another treatment approach to meet the individual needs of their patients,” explained Darrell Baker, SVP and head of global respiratory franchise at GSK, as he stated that the results proved the efficacy and safety profile of the drug.
Incruse Ellipta was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of airflow obstruction in patients who suffer from COPD. The drug is an anticholinergic, also known as a long-acting muscarinic antagonist (LAMA) with long-term effects, if taken daily.
Chronic bronchitis, emphysema or airflow obstruction are some of the conditions caused by chronic obstructive pulmonary disease, a lung disease caused by long-term exposure to lung irritants such as cigarette smoking, second hand smoke, air pollution, chemical fumes, and dust from the environment or workplace.
About 27 million people in the U.S. alone suffer from COPD and most patients experience first symptoms, as breathing difficulties and coughing, around age 40, according to the National Heart, Lung, and Blood Institute (NHLBI). GlaxoSmithKline advised that further information about the study will be presented in a future scientific meeting.