ALTANA AG’s investigational anti-inflammatory medicine roflumilast improved lung function in patients with
Chronic Obstructive Pulmonary Disease (COPD) according to a placebo controlled study presented at the annual meeting of the American Thoracic Society (ATS).
An investigational oral phosphodiesterase type-4 inhibitor, roflumilast is being co-developed by ALTANA and Pfizer Inc (NYSE: PFE) as a treatment for COPD and asthma.
“The results of this study provide an exciting indication that roflumilast may be an effective option in the management of those who suffer from COPD,” said Klaus Rabe, MD, PhD, Professor of Medicine, Leiden University Medical Center, Leiden, The Netherlands.
COPD is a progressive disease of the airways characterized by a gradual loss of lung function and is most commonly caused by smoking. The RECORD study was a 24-week double blind, placebo-controlled trial involving more than 1,400 patients in 11 countries with moderate to severe COPD.
Lung function among patients who received roflumilast (250 mcg or 500 mcg) significantly improved over placebo (p = 0.0134 and p < 0.0001, respectively) from baseline as measured by the amount of air exhaled in one second. Conversely, patients who received placebo showed a significant decline in lung function from baseline (p = 0.0041). Similarly, the amount of air exhaled in six seconds (FEV6) significantly improved during the treatment period with roflumilast (500 mcg) while significant deterioration occurred among patients who received placebo.