Investigational dual bronchodilator improves lung function over single bronchodilators in COPD

May 29, 2015

In patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), investigational indacaterol/glycopyrronium (QVA149) bromide significantly improved lung function compared to the single bronchodilators, according to data presented at the American Thoracic Society (ATS) International Conference in Denver, May 15 to 20.

In patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), investigational indacaterol/glycopyrronium (QVA149) bromide significantly improved lung function compared to the single bronchodilators, according to data presented at the American Thoracic Society (ATS) International Conference in Denver, May 15 to 20.

In the United States, QVA149 (indacaterol/ glycopyrrolate) 27.5/15.6 µg and one of its components, NVA237 (glycopyrrolate) 15.6 µg, are currently under review by FDA as twice-daily therapies for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Dr Mahler“There is an important need for additional treatment options in COPD, a progressive and life-threatening lung disease that makes it difficult to breathe,” said QVA149 investigator Donald Mahler, MD, director of respiratory services, Valley Regional Hospital, Claremont, N.H., and Emeritus Professor of Medicine, Geisel School of Medicine at Dartmouth, N.H. “COPD affects nearly 27 million people and is the third-leading cause of death in the United States. Furthermore, symptom control is a key goal of therapy.”

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Results from its phase 3 EXPEDITION trial program for QVA149 (indacaterol/glycopyrronium) in patients with moderate-to-severe COPD demonstrated that QVA149 met all primary and secondary end points.

“Treatment with QVA149 for 12 weeks provided robust bronchodilation, with clinically meaningful improvement in lung function compared to the single bronchodilators, as well as clinically meaningful improvements in breathlessness and health-related quality of life,” according to Dr Mahler.

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The EXPEDITION trial program consists of 2 efficacy studies (FLIGHT 1 and 2) and 1 safety study (FLIGHT 3). All study drugs and placebo were delivered via the Breezhaler inhalation device. The FLIGHT 1 and 2 studies met their primary end points, with QVA149 27.5/12.5 µg demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC) at week 12, compared to its individual components-indacaterol 27.5 µg and glycopyrronium 12.5 µg-and placebo, all dosed twice-daily.

Additional data presentations also showed the overall safety and tolerability of QVA149 was similar to its individual components and placebo. Nasopharyngitis and hypertension were the most common adverse reactions seen with QVA149 (incidence ≥2% and higher than placebo).

The findings for QVA149 further validate the current GOLD strategy, which recommends that maximizing bronchodilation in patients can further improve lung function, symptoms and health status, Dr Mahler added.

The studies were sponsored by Novartis.

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