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.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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)
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
|Contact: Sei Won Lee, MDfirstname.lastname@example.org|
|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|
|Seoul, Korea, Republic of, 138-736|
|Contact: Sei Won Lee, MD +82-3010-3990 email@example.com|
|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|