Patient Registry of Roflumilast In Real Life

NCT02015767 | Completed

• 2 other identifiers: RO-2455-407-RDU1111-1146-5619
• Study Type: observational
• Target: 1,950
• Locations: 6 countries
• Sites: 51

Brief Summary

A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Number of observed exacerbations

  Number of exacerbations observed during the study period and per patient per year

  12 months

Secondary Outcomes (10)

• Severity of exacerbations

  12 months

• Seasonal variation of exacerbation

  12 months

• Number of hospitalizations due to COPD exacerbations

  12 months

• Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)

  Baseline and Month 12

• Change from Baseline in blood oxygen saturation

  Baseline and Month 12

Study Arms (1)

Roflumilast

Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization. The registry sites will comprise hospitals, and office-based physicians. The investigators will be mainly pulmonologists, or as per the standard practice of the specific country.

You may qualify if:

• Signed informed consent to the data collection
• Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (51)

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Pleven, Bulgaria

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Razgrad, Bulgaria

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Sofia, Bulgaria

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Troyan Municipality, Bulgaria

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Vratsa, Bulgaria

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Agrinio, Greece

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Athens, Greece

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Edessa, Greece

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Herakleion-Crete, Greece

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Imitos, Greece

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Kaisarianí, Greece

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Kalamaria, Greece

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Katerini, Greece

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Nafpaktos, Greece

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Pátrai, Greece

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Peristeri, Greece

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Piraeus, Greece

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Ptolemaida, Greece

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Pýrgos, Greece

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Thessaloniki, Greece

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Volos, Greece

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Hong Kong, Hong Kong

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Arendal, Norway

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Bergen, Norway

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Elverum, Norway

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Fredrikstad, Norway

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Kongsvinger, Norway

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Sandvika, Norway

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Skien, Norway

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Straume, Norway

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Tønsberg, Norway

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Banská Bystrica, Slovakia

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Bardejov, Slovakia

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Bratislava, Slovakia

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Humenné, Slovakia

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Malacky, Slovakia

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Michalovce, Slovakia

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Nitra, Slovakia

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Považská Bystrica, Slovakia

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Prešov, Slovakia

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Revúca, Slovakia

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Senica, Slovakia

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Spišská Nová Ves, Slovakia

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Štúrovo, Slovakia

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Topoľčany, Slovakia

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Busan, South Korea

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Daegu, South Korea

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Gwangju, South Korea

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Jeonju, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: February 1, 2013
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: June 23, 2017

Record last verified: 2017-05

Locations

KR (6); BU (5); NO (9); SL (14); GR (16); HK (1)