Phase 3 Drug Improves Lung Function for COPD Patients with Symptoms After Tiotropium

Phase 3 Drug Improves Lung Function for COPD Patients with Symptoms After Tiotropium

A new phase 3 clinical study conducted by the pharmaceutical companies GlaxoSmithKline (GSK) and Innoviva, Inc. showed that the drug Anoro Ellipta significantly improves lung function in people with chronic obstructive pulmonary disease (COPD), who remain symptomatic even after taking another drug called tiotropium.

The results were presented at the American Thoracic Society (ATS) 2016 International Conference.

Anoro Ellipta contains a combination of two active substances, umeclidinium and vilanterol, that belong to a group of medicines called bronchodilators which make breathing easier  by relaxing the muscles around airways.

In a press release, professor Neil Barnes, Global Respiratory Franchise Medical Head at GSK, noted: “For COPD patients who remain symptomatic it is important that their lung function is optimized effectively. These efficacy data demonstrate the improvement in lung function that can be achieved in patients with moderate COPD when changing treatment from monotherapy with tiotropium 18mcg to dual bronchodilation with Anoro Ellipta.”

Dr. Ted Witek, chief scientific officer of Innoviva, Inc., said the data “adds to the growing evidence base that shows that use of two mechanistic pathways can help symptomatic patients with COPD to improve their lung function.”

For the study, 494 patients with moderate COPD, 40 years old and older, were enrolled at sites worldwide that included the U.S., Europe, South America, and South Africa. All participants were already taking tiotropium for at least three months before the start of the study, but remained symptomatic. At the beginning of the trial, all participants were given tiotropium for an additional four weeks before randomly being split into two groups – one group continued to take tiotropium while the other received Anoro Ellipta treatment. Neither the patients nor the clinicians knew who was getting which drug.

After a 12-week period of once daily administration of either drug, statistics revealed a significant improvement in lung function among participants taking Anoro Ellipta compared to those taking tiotropium. Improvement was observed only three hours after the drugs were taken.

The most common side effects reported during the study were nasopharyngitis (or blocked nose) and headaches. The rate of these side effects was the same for both drugs.

COPD is a lung disease characterized by inflamed airways that causing obstruction and making breathing difficult. The main cause of COPD is smoking, but it can also be caused by long-term exposure to lung irritants such as air pollution, fumes, and dust from the environment.

According to the World Health Organization (WHO), 65 million people are affected by COPD worldwide.

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