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.
Study Type
OBSERVATIONAL
Enrollment
1,950
Number of observed exacerbations
Number of exacerbations observed during the study period and per patient per year
Time frame: 12 months
Severity of exacerbations
Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization).
Time frame: 12 months
Seasonal variation of exacerbation
Seasonal variation of exacerbation during Roflumilast treatment.
Time frame: 12 months
Number of hospitalizations due to COPD exacerbations
Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Month 12
Percentage of compliance to treatment
Estimated percentage of prescribed doses taken since the last date of data collection.
Time frame: 12 months
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Unnamed facility
Pleven, Bulgaria
Unnamed facility
Razgrad, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Troyan Municipality, Bulgaria
Unnamed facility
Vratsa, Bulgaria
Unnamed facility
Agrinio, Greece
Unnamed facility
Athens, Greece
Unnamed facility
Edessa, Greece
Unnamed facility
Herakleion-Crete, Greece
Unnamed facility
Imitos, Greece
...and 41 more locations
Changes in concomitant administration of COPD maintenance treatments
Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment.
Time frame: 12 months
Health status using the COPD Assessment Questionnaire (CAT)
Time frame: 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.
Time frame: 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.
Time frame: 12 months