A Phase 4 interventional study of Roflumilast escalation dosage and Roflumilast conventional dosage in Chronic Obstructive Pulmonary Disease, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-12-23.
Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment
Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache, diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild or moderate. They occurred mainly at the beginning of therapy and mostly resolved with continued treatment around for two weeks according to experiences of clinicians. These adverse events occur more often in Roflumilast 500 μg than 250 μg, having negative impact on compliance of patients at the early stage of treatments.
Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast 500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and then escalating dose of 500 μg once daily).
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Roflumilast 250 μg qd (4 weeks) →500 μg qd
Drug: Roflumilast escalation dosage
Roflumilast 500 μg qd
Drug: Roflumilast conventional dosage
This is a randomized, prospective, open label, comparative study to assess whether the administration of roflumilast by dose escalation varies the incidence of discontinuations due to adverse events when compared with the usual dosage in severe and very severe COPD patients. Roflumilast 250 μg once daily for 4 weeks and then increased dose of Roflumilast 500 μg once daily for 12 weeks
Also known as: Daxas
Roflumilast 500 μg once daily for 12 weeks
Also known as: Daxas
medication(Roflumilas) history taking
In every follow-up, patients will be asked about their medication history. The patients will count the rest of the Roflumilast that they are going to take in the future.
Time frame: 16 weeks
Laboratory test : Hematology, Biochemistry, and Urinalysis
•Laboratory test : Hematology, Biochemistry, and Urinalysis
Time frame: 16 weeks
Urine pregnancy test
•Urine pregnancy test
Time frame: 16 weeks
Chest X-ray Test
•Chest X-ray Test
Time frame: 16 weeks
ECG Test
•ECG Test
Time frame: 16 weeks
Lung Function Test
•Lung Function Test
Time frame: 16 weeks
QoL Questionnaire (CAT score)
•QoL Questionnaire (CAT score)
Time frame: 16 weeks
Other tests (HBsAg, HCV, HIV)
•Other tests (HBsAg, HCV, HIV)
Time frame: 16 weeks
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asan Medical Center