Roflumilast represents the first in a new class of agents to treat COPD and, if approved, would be the first oral anti-inflammatory maintenance treatment for the disease.
Exacerbations are frightening events resulting in increased patient anxiety, worsening health status, lung function decline and increased risk of death.
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In four studies, two 12-month studies and two six-month studies, roflumilast showed clear therapeutic potential, decreasing exacerbations and improving lung function.
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One 12 month study was conducted in 246 centres in 10 countries and the second was conducted in 221 centres in eight countries.
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