Chronic Obstructive Pulmonary Disease Clinical Trial
To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD patient.
Roflumilast is a product which has been approved for the treatment of severe chronic
obstructive lung disease (COPD) and its approved dose is 500μg once daily. This study is
primarily designed to see whether alternation in this dose can improve tolerability of
Roflumilast in COPD patients. Therefore one in three patients will start roflumilast therapy
at a lower dose of 250μg/375μg once daily, another one in three will only take the 500μg
tablet every day (and one placebo every day). Furthermore, the study will evaluate the safety
and pharmacokinetics of different dose roflumilast in China COPD patient.
Lastly, the study will investigate what the body does to roflumilast. Patients with a history
of COPD for at least last 12 months and a former smoker or current smoker with history of at
least 10 pack years will be invited to participate.
The Randomization visit is considered the Baseline visit and for participants that
discontinue the Main Period and continue into the Down-Titration Period Day 1 of Down
Titration is considered BaselineDT.
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