Study identifier:RO-2455-402-KR
ClinicalTrials.gov identifier:NCT02068456
EudraCT identifier:N/A
CTIS identifier:N/A
Post Marketing Surveillance of Roflumilast in Korea
Chronic Obstructive Pulmonary Disease
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No
Roflumilast
All
1837
Observational
18 Years +
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jun 2017 by AstraZeneca
AstraZeneca
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The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.
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.
Location
Location
Seoul, Republic of Korea
Arms | Assigned Interventions |
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Roflumilast Roflumilast will be administered according to the prescribing information of the approved Korean label. | Drug: Roflumilast N/A Other Name: Daxas, Daliresp |
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