Strategy to Improve Adherence of Roflumilast

Sponsor
Asan Medical Center
Study ID
NCT02018432
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast escalation dosage — DRUG
    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
  • Roflumilast conventional dosage — DRUG
    Roflumilast 500 μg once daily for 12 weeks

Study Details

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).

Key Dates

Start date
Dec 31, 2013
Status verified
Dec 2013
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast escalation dosage
    Roflumilast 250 μg qd (4 weeks) →500 μg qd
  • Experimental: Roflumilast conventional dosage
    Roflumilast 500 μg qd

Primary Outcome Measure

medication(Roflumilas) history taking [ Time Frame: 16 weeks ]

Central Contacts

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