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Strategy to Improve Adherence of Roflumilast

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02018432
Recruitment Status : Unknown
Verified December 2013 by Sei Won Lee, Asan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2013
Last Update Posted : December 23, 2013
Information provided by (Responsible Party):
Sei Won Lee, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE December 12, 2013
First Posted Date  ICMJE December 23, 2013
Last Update Posted Date December 23, 2013
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
medication(Roflumilas) history taking [ Time Frame: 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
  • Laboratory test : Hematology, Biochemistry, and Urinalysis [ Time Frame: 16 weeks ]
    •Laboratory test : Hematology, Biochemistry, and Urinalysis
  • Urine pregnancy test [ Time Frame: 16 weeks ]
    •Urine pregnancy test
  • Chest X-ray Test [ Time Frame: 16 weeks ]
    •Chest X-ray Test
  • ECG Test [ Time Frame: 16 weeks ]
    •ECG Test
  • Lung Function Test [ Time Frame: 16 weeks ]
    •Lung Function Test
  • QoL Questionnaire (CAT score) [ Time Frame: 16 weeks ]
    •QoL Questionnaire (CAT score)
  • Other tests (HBsAg, HCV, HIV) [ Time Frame: 16 weeks ]
    •Other tests (HBsAg, HCV, HIV)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Strategy to Improve Adherence of Roflumilast
Official Title  ICMJE Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Roflumilast escalation 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

    Other Name: Daxas
  • Drug: Roflumilast conventional dosage
    Roflumilast 500 μg once daily for 12 weeks
    Other Name: Daxas
Study Arms  ICMJE
  • Experimental: Roflumilast escalation dosage
    Roflumilast 250 μg qd (4 weeks) →500 μg qd
    Intervention: Drug: Roflumilast escalation dosage
  • Experimental: Roflumilast conventional dosage
    Roflumilast 500 μg qd
    Intervention: Drug: Roflumilast conventional dosage
Publications * Park TS, Kang J, Lee JS, Oh YM, Lee SD, Lee SW. Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Apr 16;14:871-879. doi: 10.2147/COPD.S191033. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 17, 2013)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female older than 40 years
  2. Clinical diagnosis of COPD (confirmed with a post-bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ratio ≤70%) at least 4 weeks prior to the study and post-bronchodilator FEV1 is 50% or less than the predicted value
  3. Former smokers or current smokers with at least a 10 pack-year history
  4. A history of exacerbation (scheduled/unscheduled visits to primary care physicians, specialists or allied healthcare professionals, or emergency room, or hospitalization due to purulent sputum or increased sputum, or increased dyspnea) in the previous year (at least one)
  5. Chronic bronchitis (cough and sputum production for at least three months within two years)
  6. Able to have the signed written informed consent prior to any study-related procedures.

Exclusion Criteria:

  1. COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit
  2. Known a1-antitrypsin deficiency
  3. Need for long-term oxygen therapy
  4. Moderate to severe liver impairment (Child-Pugh B or C)
  5. Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc)
  6. Severe acute infectious diseases
  7. Cancers
  8. Subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term) except short-term systemic corticosteroids)
  9. Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster
  10. Subjects with congestive heart failure (NYHA grades 3 and 4)
  11. Subjects with a history of depression associated with suicidal ideation or behavior
  12. Clinically meaningful bronchiectasis
  13. Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception
  14. Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients
  15. Patients with previous Roflumilast therapy within past 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02018432
Other Study ID Numbers  ICMJE Roflumilast_compliance
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sei Won Lee, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sei Won Lee, MD 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, Republic of Korea
PRS Account Asan Medical Center
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP