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A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries. The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study. Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Pleven, Bulgaria
Razgrad, Bulgaria
Sofia, Bulgaria
Troyan Municipality, Bulgaria
Vratsa, Bulgaria
Agrinio, Greece
Athens, Greece
Edessa, Greece
Herakleion-Crete, Greece
Imitos, Greece
Start Date
February 1, 2013
Primary Completion Date
August 31, 2016
Completion Date
August 31, 2016
Last Updated
June 23, 2017
1,950
ESTIMATED participants
Lead Sponsor
AstraZeneca
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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