COPD is an inflammatory airway disease with progressive decline in lung function and health-related quality of life.
Roflumilast is a promising candidate for treatment of the lung disease because it improved lung function and reduced exacerbations of symptoms compared with placebo, write the researchers.
The study was sponsored by Altana Pharma AG, roflumilast's maker. The company also managed the data and did all the final analyses, write the researchers.
COPD is the No. 5 cause of death worldwide, write the researchers. They included professor Klaus Rabe, MD, of Leiden University Medical Centre in the Netherlands.
Cases of COPD are rising and treatment options are "limited," write the researchers. They note predictions that COPD -- which causes progressive worsening of breathing and destruction of the lungs -- will be the world's No. 3 cause of death by 2020.
"The disease is usually related to cigarette smoking, but other [causes], such as exposure to air pollution, exist," write Rabe and colleagues.
Steroids do not reduce the progression of the disease, they write. Bronchodilators provide some symptom relief, but there is a definite unmet medical need that specifically targets inflammation associated with COPD, they add.
Roflumilast is designed to soothe inflammation. It's part of a class of drugs called phosphodiesterase-4 inhibitors, which inhibit a particular chemical in inflammatory cells that cause progressive lung tissue destruction.
The new study was conducted in 11 countries. Participants were all at least 40 years old, had had COPD for more than a year, and were current or ex-smokers. None had asthma, lung cancer, or other lung diseases in addition to COPD.
Participants were randomly assigned to take roflumilast or the placebo orally once daily for 24 weeks. They didn't know which treatment they got.
Patients taking roflumilast had significantly bigger improvements in lung function and health-related quality of life than those taking the placebo, write the researchers.
Two daily doses of roflumilast were tested (250 or 500 milligrams). Both doses had similar quality-of-life results, the study shows.
Some COPD flare-ups ("exacerbations") happened in each group. There were fewer exacerbations with roflumilast than with the placebo. Those taking the higher dose of roflumilast had the fewest exacerbations, write the researchers.
Diarrhea was the most common side effect associated with roflumilast. It was reported by 13 people taking the drug's low dose (2%), 34 patients taking the higher dose (6%), and none of those taking the placebo.