Anti-inflammatory medicine Roflumilast improved lung function in patients with chronic obstructive pulmonary disease

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.

In addition, patients treated with roflumilast (500 mcg) had 34 percent fewer exacerbations compared with placebo. The mean number of exacerbations in the roflumilast treatment group was 1.03 and 0.75 for the 250 mcg and 500 mcg, respectively, compared to 1.13 for the placebo group over the 24-week trial period (p = 0.029). Exacerbations typically require increase use of bronchodilator or steroid therapy and/or physician and emergency room visits to control symptoms.

Roflumilast was generally well tolerated in the treatment of patients with COPD. Side effects due to study medication (250 mcg, 500 mcg) included diarrhea (2.3%, 6.1%), nausea (1.0%, 3.2%), headache (0.7%, 1.8%) and abdominal pain (0.2%, 1.6%). Most were mild or moderate in severity and only a small number of patients (< 3%) with these side effects discontinued the study.

“These results indicate we may have a new therapeutic modality to improve lung function in COPD patients with an anti-inflammatory,” said Professor Rabe. “The 34 percent reduction in exacerbations appears to be promising for roflumilast to impact this important indicator of morbidity.”  http://www.altana.de