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Strategy to Improve Adherence of Roflumilast

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Sei Won Lee, Asan Medical Center

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).


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Roflumilast escalation dosage Drug: Roflumilast conventional dosage Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
Drug Information available for: Roflumilast

Arm Intervention/treatment
Experimental: Roflumilast escalation dosage
Roflumilast 250 μg qd (4 weeks) →500 μg qd
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

Experimental: Roflumilast conventional dosage
Roflumilast 500 μg qd
Drug: Roflumilast conventional dosage
Roflumilast 500 μg once daily for 12 weeks
Other Name: Daxas




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Laboratory test : Hematology, Biochemistry, and Urinalysis [ Time Frame: 16 weeks ]
    •Laboratory test : Hematology, Biochemistry, and Urinalysis

  2. Urine pregnancy test [ Time Frame: 16 weeks ]
    •Urine pregnancy test

  3. Chest X-ray Test [ Time Frame: 16 weeks ]
    •Chest X-ray Test

  4. ECG Test [ Time Frame: 16 weeks ]
    •ECG Test

  5. Lung Function Test [ Time Frame: 16 weeks ]
    •Lung Function Test

  6. QoL Questionnaire (CAT score) [ Time Frame: 16 weeks ]
    •QoL Questionnaire (CAT score)

  7. Other tests (HBsAg, HCV, HIV) [ Time Frame: 16 weeks ]
    •Other tests (HBsAg, HCV, HIV)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018432


Contacts
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Contact: Sei Won Lee, MD +82-2-3010-3990 iseiwon@gmail.com

Locations
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Korea, Republic of
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 Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sei Won Lee, MD    +82-3010-3990    iseiwon@gmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sei Won Lee, 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, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02018432     History of Changes
Other Study ID Numbers: Roflumilast_compliance
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases