Chronic Obstructive Pulmonary DiseasePhase 4NCT02018432
Strategy to Improve Adherence of Roflumilast
A Phase 4 study testing Roflumilast escalation dosage and Roflumilast conventional dosage in people with Chronic Obstructive Pulmonary Disease, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Roflumilast escalation dosage and Roflumilast conventional dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
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, 138-736
Sei Won Lee, MD, +82-3010-3990, iseiwon@gmail.com
About this study
Official title: Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Roflumilast escalation dosage, Roflumilast conventional dosage
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast escalation dosageDrug
Also called Daxas
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 dosageDrug
Also called Daxas
Roflumilast 500 μg once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast escalation dosage | Experimental | Roflumilast 250 μg qd (4 weeks) →500 μg qd Receives: Drug: Roflumilast escalation dosage |
| Roflumilast conventional dosage | Experimental | Roflumilast 500 μg qd Receives: Drug: Roflumilast conventional dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (7)
Laboratory test : Hematology, Biochemistry, and Urinalysis
•Laboratory test : Hematology, Biochemistry, and Urinalysis
Measured: 16 weeks
Urine pregnancy test
•Urine pregnancy test
Measured: 16 weeks
Chest X-ray Test
•Chest X-ray Test
Measured: 16 weeks
ECG Test
•ECG Test
Measured: 16 weeks
Lung Function Test
•Lung Function Test
Measured: 16 weeks
QoL Questionnaire (CAT score)
•QoL Questionnaire (CAT score)
Measured: 16 weeks
Other tests (HBsAg, HCV, HIV)
•Other tests (HBsAg, HCV, HIV)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
- Investigators
- Sei Won Lee, MD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018432
- Sponsor's protocol ID
- Roflumilast_compliance
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31354255
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
- ClinicalTrials.gov ID
- NCT02018432
- Acronym / sponsor ID
- Roflumilast_compliance
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast escalation dosage | Experimental | Drug: Roflumilast escalation dosageRoflumilast 250 μg qd (4 weeks) →500 μg qd |
| Roflumilast conventional dosage | Experimental | Drug: Roflumilast conventional dosageRoflumilast 500 μg qd |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast escalation dosageAlso: DaxasThis 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 | Drug | Roflumilast escalation dosage |
| Roflumilast conventional dosageAlso: DaxasRoflumilast 500 μg once daily for 12 weeks | Drug | Roflumilast conventional dosage |
Primary outcome
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.
7 secondary outcomes
Laboratory test : Hematology, Biochemistry, and Urinalysis
Time frame: 16 weeks
Urine pregnancy test
Time frame: 16 weeks
Chest X-ray Test
Time frame: 16 weeks
ECG Test
Time frame: 16 weeks
Lung Function Test
Time frame: 16 weeks
QoL Questionnaire (CAT score)
Time frame: 16 weeks
Other tests (HBsAg, HCV, HIV)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Derived from this study: PubMed 31354255Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sei Won Lee, MD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast escalation dosage and Roflumilast conventional dosage in people with Chronic Obstructive Pulmonary Disease, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sei Won Lee, MD (+82-2-3010-3990, iseiwon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication(Roflumilas) history taking (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2013.