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Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
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).
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Start Date
December 1, 2013
Primary Completion Date
December 1, 2015
Completion Date
December 1, 2015
Last Updated
December 23, 2013
80
ESTIMATED participants
Roflumilast escalation dosage
DRUG
Roflumilast conventional dosage
DRUG
Lead Sponsor
Asan Medical Center
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
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