Post Marketing Surveillance of Roflumilast in Korea
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|ClinicalTrials.gov Identifier: NCT02068456|
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease||Drug: Roflumilast|
The drug being tested in this study is called roflumilast. Roflumilast is used to treat people who have severe chronic obstructive pulmonary disease (COPD) forced expiratory volume in 1 second (FEV1) post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of worsening symptoms. This study will look at side effects and the lung function of people who take roflumilast.
The study will enroll approximately 3000 patients who plan to take roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial will be conducted in Korea.. The administration period of the roflumilast is determined in accordance with actual treatment policy for the subject, Subjects will be evaluated during routine appointments with their healthcare provider.
This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 1 month. Participants will be evaluated during routine appointments with their healthcare provider.
|Study Type :||Observational|
|Actual Enrollment :||1837 participants|
|Official Title:||Post Marketing Surveillance of Roflumilast in Korea|
|Actual Study Start Date :||September 18, 2012|
|Actual Primary Completion Date :||April 26, 2017|
|Actual Study Completion Date :||April 26, 2017|
Roflumilast will be administered according to the prescribing information of the approved Korean label.
Other Name: Daxas, Daliresp
- Number of participants with adverse events and adverse drug reactions [ Time Frame: Baseline to at least 1 month after administration of Roflumilast . ]An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. An Adverse Drug Reaction (ADR) is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in humans. A serious AE or ADR is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
- Effectiveness of treatment [ Time Frame: Baseline to at least 1 month after administration of Roflumilast ]
After at least 1 month of administration of Roflumilast the Investigator will classify the effectiveness of treatment relative to Baseline taking into account the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2010 Guidelines using the following classification:
- Improvement: if the symptom is deemed to take a turn for a better
- No Change: if no particular changes are shown compared to before administration
- Worsening: the symptom is worsened compared to before administration
- Un-assessable: the symptom is not able to be evaluated.
- Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to at least 1 month after administration of Roflumilast ]FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation and is measured by spirometry.
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): NCT02068456
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||AstraZeneca AstraZeneca||AstraZeneca|