Patient Registry of Roflumilast In Real Life

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

Detailed Description
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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.

Official Title
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Patient Registry of Roflumilast In Real Life

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent to the data collection Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry Exclusion Criteria: There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roflumilast<br>Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of observed exacerbations | Number of exacerbations observed during the study period and per patient per year | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of exacerbations | Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization). | 12 months | 
| Seasonal variation of exacerbation | Seasonal variation of exacerbation during Roflumilast treatment. | 12 months | 
| Number of hospitalizations due to COPD exacerbations | Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year. | 12 months | 
| Change from Baseline in lung function parameters (FEV1 and FEV1/FVC) | Change in lung function parameters parameters FEV1(Forced Expired Volume measured after 1 second expiration) and FEV1/FVC (Forced Vital Capacity) from Baseline to the last recorded value and to the end of the study. | Baseline and Month 12 | 
| Change from Baseline in blood oxygen saturation | Change in blood oxygen saturation assessed with pulse oximetry from Baseline to the last recorded value and the end of the study. | Baseline and Month 12 | 
| Percentage of compliance to treatment | Estimated percentage of prescribed doses taken since the last date of data collection. | 12 months | 
| Changes in concomitant administration of COPD maintenance treatments | Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment. | 12 months | 
| Health status using the COPD Assessment Questionnaire (CAT) |  | Baseline, Month 6 and Month 12 | 
| Change from Baseline in breathlessness | Change in breathlessness assessed using the Modified Medical Research Council (mMRC) dyspnoea scale, from Baseline to the end of observation. | Baseline and Month 12 | 
| Number of Participants with adverse Drug Reactions (ADRs) | An ADR is a response to an observed medicinal product which is noxious and unintended resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy