OPTIMIZE RO-2455-302-RD Roflumilast for severe COPD
Research type
Research Study
Full title
A multicenter, randomized, double-blind phase 3 study to evaluate tolerability and pharmacokinetics of 500 µg roflumilast once daily with an up-titration regimen in COPD,including an open-label down-titration period evaluating tolerability and pharmacokinetics of 250 µg roflumilast once daily in subjects not tolerating 500 µg roflumilast once-daily. Short title: Evaluation of tolerability and pharmacokinetics of roflumilast, 250 µg and 500 µg, as add-on to standard COPD treatment to treat severe COPD – the OPTIMIZE study.
IRAS ID
148058
Contact name
Peter Calverley
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2013-001788-21
Research summary
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 once-daily, another one in three will only take the 500μg tablet every other day (and one placebo every other day). Rest of them will start the regular dose of 500μg once-daily right away and see whether starting with a lower dose of Roflumilast will lead to better tolerability. Furthermore, the study will see if patients who do not tolerate roflumilast should be given a lower dose of 250μg once-daily. 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 main study period lasts for a maximum of 15 weeks and patients will have to visit the study site up to 6 times. If patients experience non-acceptable side effects, the investigators may switch them to the lower dose for rest of the study. Then patients will remain in the down-titration period for additional 8 weeks and will have to visit the study site 4 times. Most of the visits will take approximately 1 to 2 hours. However, one visit in the main period and 1 or 2 visits in the down-titration period will take approximately 6 to 7 hours. These visits are longer to allow time to conduct blood taking.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0138
Date of REC Opinion
11 Apr 2014
REC opinion
Further Information Favourable Opinion