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Strategy to Improve Adherence of Roflumilast

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Roflumilast escalation dosage

Roflumilast conventional dosage

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female older than 40 years
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
Former smokers or current smokers with at least a 10 pack-year history
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)
Chronic bronchitis (cough and sputum production for at least three months within two years)
Able to have the signed written informed consent prior to any study-related procedures.

Exclusion Criteria:

COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit
Known a1-antitrypsin deficiency
Need for long-term oxygen therapy
Moderate to severe liver impairment (Child-Pugh B or C)
Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc)
Severe acute infectious diseases
Cancers
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)
Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster
Subjects with congestive heart failure (NYHA grades 3 and 4)
Subjects with a history of depression associated with suicidal ideation or behavior
Clinically meaningful bronchiectasis
Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception
Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients
Patients with previous Roflumilast therapy within past 3 months

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Roflumilast escalation dosage

Roflumilast conventional dosage

Arm Description

Roflumilast 250 μg qd (4 weeks) →500 μg qd

Roflumilast 500 μg qd

Outcomes

Primary Outcome Measures

medication(Roflumilas) history taking

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

Laboratory test : Hematology, Biochemistry, and Urinalysis

•Laboratory test : Hematology, Biochemistry, and Urinalysis

Urine pregnancy test

•Urine pregnancy test

Chest X-ray Test

•Chest X-ray Test

ECG Test

•ECG Test

Lung Function Test

•Lung Function Test

QoL Questionnaire (CAT score)

•QoL Questionnaire (CAT score)

Other tests (HBsAg, HCV, HIV)

•Other tests (HBsAg, HCV, HIV)

Full Information

NCT ID

NCT02018432

First Posted

December 12, 2013

Last Updated

December 17, 2013

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02018432

Brief Title

Strategy to Improve Adherence of Roflumilast

Official Title

Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Roflumilast escalation dosage

Arm Type

Experimental

Arm Description

Roflumilast 250 μg qd (4 weeks) →500 μg qd

Arm Title

Roflumilast conventional dosage

Arm Type

Experimental

Arm Description

Roflumilast 500 μg qd

Intervention Type

Drug

Intervention Name(s)

Roflumilast escalation dosage

Other Intervention Name(s)

Daxas

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Roflumilast conventional dosage

Other Intervention Name(s)

Daxas

Intervention Description

Roflumilast 500 μg once daily for 12 weeks

Primary Outcome Measure Information:

Title

medication(Roflumilas) history taking

Description

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.

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Laboratory test : Hematology, Biochemistry, and Urinalysis

Description

•Laboratory test : Hematology, Biochemistry, and Urinalysis

Time Frame

16 weeks

Title

Urine pregnancy test

Description

•Urine pregnancy test

Time Frame

16 weeks

Title

Chest X-ray Test

Description

•Chest X-ray Test

Time Frame

16 weeks

Title

ECG Test

Description

•ECG Test

Time Frame

16 weeks

Title

Lung Function Test

Description

•Lung Function Test

Time Frame

16 weeks

Title

QoL Questionnaire (CAT score)

Description

•QoL Questionnaire (CAT score)

Time Frame

16 weeks

Title

Other tests (HBsAg, HCV, HIV)

Description

•Other tests (HBsAg, HCV, HIV)

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female older than 40 years 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 Former smokers or current smokers with at least a 10 pack-year history 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) Chronic bronchitis (cough and sputum production for at least three months within two years) Able to have the signed written informed consent prior to any study-related procedures. Exclusion Criteria: COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit Known a1-antitrypsin deficiency Need for long-term oxygen therapy Moderate to severe liver impairment (Child-Pugh B or C) Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc) Severe acute infectious diseases Cancers 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) Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster Subjects with congestive heart failure (NYHA grades 3 and 4) Subjects with a history of depression associated with suicidal ideation or behavior Clinically meaningful bronchiectasis Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients Patients with previous Roflumilast therapy within past 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sei Won Lee, MD

Phone

+82-2-3010-3990

iseiwon@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sei Won Lee, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sei Won Lee, MD

Phone

+82-3010-3990

iseiwon@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

31354255

Citation

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.

Results Reference

derived

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Strategy to Improve Adherence of Roflumilast

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