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Core Evid. 2005;1(1):23-33. Epub 2005 Mar 31.

Roflumilast: the evidence for its clinical potential in the treatment of chronic obstructive pulmonary disease.

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MLC Solutions Ltd, Galena, Ohio, USA.



Chronic obstructive pulmonary disease (COPD), characterized by a progressive deterioration of lung function caused primarily by the inhalation of toxic substances, is a leading cause of morbidity and mortality worldwide. Current treatment options for the management of its symptoms include the use of bronchodilators and glucocorticoid agents that are not universally beneficial and which are associated with limitations. Phosphodiesterase-4 (PDE4) inhibitors are a novel class of antiinflammatory agents being developed for COPD treatment.


The purpose of this article is to review the clinical potential of roflumilast, a PDE4 inhibitor currently in phase III clinical trials, in the management of patients with COPD.


Phase II studies indicate that roflumilast can be given orally once daily. Preliminary evidence from two phase III, randomized, double-blind, placebo-controlled studies suggest that roflumilast improves or stabilizes lung function, as measured by forced expiratory volume in 1 s and 6 s (FEV(1) and FEV(6)), forced vital capacity (FVC), and peak expiratory flow (PEF) in patients with COPD. Improvements in COPD exacerbation rate were also reported in these trials. Quality of life, as measured by the St George's Respiratory Questionnaire, also improved with roflumilast treatment. Clinical studies to date suggest that roflumilast is well tolerated.


Current evidence supports the use of roflumilast in the management of COPD as shown by improvements in patients' symptoms and quality of life, and good tolerability profile. Its once-daily oral dosing regimen is unique among current therapies for COPD. This potential and the place of roflumilast in the stepwise management of the disease need to be confirmed as further evidence is published. Additional evidence will also be welcome to determine if its mechanism of action moderates the progression of lung function deterioration.


COPD; evidence; outcomes; roflumilast; treatment

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