Strategy to Improve Adherence of Roflumilast

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Chronic Obstructive Pulmonary Disease
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Clinical Trial Details

NCT number	NCT02018432
Study type	Interventional
Source	Asan Medical Center
Contact	Sei Won Lee, MD
Phone	+82-2-3010-3990
Email	iseiwon@gmail.com
Status	Not yet recruiting
Phase	Phase 4
Start date	December 2013
Completion date	December 2015

View Details

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