Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1950 participants
OBSERVATIONAL
2013-02-01
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Roflumilast
Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Pleven, , Bulgaria
Razgrad, , Bulgaria
Sofia, , Bulgaria
Troyan Municipality, , Bulgaria
Vratsa, , Bulgaria
Agrinio, , Greece
Athens, , Greece
Edessa, , Greece
Herakleion-Crete, , Greece
Imitos, , Greece
Kaisarianí, , Greece
Kalamaria, , Greece
Katerini, , Greece
Nafpaktos, , Greece
Pátrai, , Greece
Peristeri, , Greece
Piraeus, , Greece
Ptolemaida, , Greece
Pýrgos, , Greece
Thessaloniki, , Greece
Volos, , Greece
Hong Kong, , Hong Kong
Arendal, , Norway
Bergen, , Norway
Elverum, , Norway
Fredrikstad, , Norway
Kongsvinger, , Norway
Sandvika, , Norway
Skien, , Norway
Straume, , Norway
Tønsberg, , Norway
Banská Bystrica, , Slovakia
Bardejov, , Slovakia
Bratislava, , Slovakia
Humenné, , Slovakia
Malacky, , Slovakia
Michalovce, , Slovakia
Nitra, , Slovakia
Považská Bystrica, , Slovakia
Prešov, , Slovakia
Revúca, , Slovakia
Senica, , Slovakia
Spišská Nová Ves, , Slovakia
Štúrovo, , Slovakia
Topoľčany, , Slovakia
Busan, , South Korea
Daegu, , South Korea
Gwangju, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Countries
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Related Links
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Other Identifiers
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U1111-1146-5619
Identifier Type: OTHER
Identifier Source: secondary_id
RO-2455-407-RD
Identifier Type: -
Identifier Source: org_study_id
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