Patient Registry of Roflumilast In Real Life
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT02015767
- Lead Sponsor
- AstraZeneca
- Brief Summary
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1950
- Signed informed consent to the data collection
- Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry
There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of observed exacerbations 12 months Number of exacerbations observed during the study period and per patient per year
- Secondary Outcome Measures
Name Time Method Change from Baseline in blood oxygen saturation Baseline and Month 12 Change in blood oxygen saturation assessed with pulse oximetry from Baseline to the last recorded value and the end of the study.
Changes in concomitant administration of COPD maintenance treatments 12 months Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment.
Severity of exacerbations 12 months Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization).
Number of hospitalizations due to COPD exacerbations 12 months Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year.
Change from Baseline in lung function parameters (FEV1 and FEV1/FVC) Baseline and Month 12 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.
Percentage of compliance to treatment 12 months Estimated percentage of prescribed doses taken since the last date of data collection.
Number of Participants with adverse Drug Reactions (ADRs) 12 months 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.
Change from Baseline in breathlessness Baseline and Month 12 Change in breathlessness assessed using the Modified Medical Research Council (mMRC) dyspnoea scale, from Baseline to the end of observation.
Seasonal variation of exacerbation 12 months Seasonal variation of exacerbation during Roflumilast treatment.
Health status using the COPD Assessment Questionnaire (CAT) Baseline, Month 6 and Month 12