Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT02018432
Status:
UNKNOWN
Last Update Posted:
2013-12-23
First Post:
2013-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strategy to Improve Adherence of Roflumilast
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: