Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Non Interventional, Observational, Multi-center Study to Evaluate the Efficacy and Safety of Fluticasone/Salmeterol (Rolenium / Elpenhaler Administration in Greek COPD Pattients
Observational study for the evaluation of clinical effectiveness in daily clinical practice of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg - Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy in Greece.
The scientific Objectives are to study in the Greek population the real-life patient
characteristics of patients selected for treatment with the inhaled combination of propionic
Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device and
the performance of this inhaled combination in terms of effectiveness and safety in
approximately 2500 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50%
predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have
significant symptoms despite regular bronchodilator therapy treated in Hospital and
outpatient specialist ward settings, in the daily clinical practice
The primary endpoints for the study are:
• Change in FEV1, FVC, FEV1/FVC from baseline to 12 months (±2 weeks) from starting taking
Rolenium®.
The Secondary endpoints for the study are:
- Change in lung function parameters from baseline to month 6 (±2 weeks) from start of
Rolenium® treatment
- Incidence and frequency of exacerbations
- Hospitalizations due to COPD exacerbation
- Change in MRC Dyspnea index.
- Patient's satisfaction with the use of Elpenhaler device assessed with FSI 10
Questionnaire after 6 months and after 12 months (±2 weeks).
- Concomitant administration of inhaled bronchodilators
- ADRs during the treatment period (only via the post-marketing procedure). Methodology
The study will be a purely observational, prospective study, collecting data on patient
treated with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)
mcg,- administered with Elpenhaler device in Greece without any interference with the
treatment practices of the physicians involved in the data collection. Thus patients
will only be considered for inclusion after the decision has been taken to treat them
with inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg
administered with Elpenhaler device and no visits, diagnostic procedures or monitoring
will take place which would not happen had the patient not been included in the study.
This means that only data generated in usual daily clinical practice will be collected
in the study, so that no extra examinations or study visits will take place due to the
study. The study will not be comparative; only inhaled combination of propionic
Fluticasone and Salmeterol (500+50)mcg,- administered with Elpenhaler device will be
included. Consecutive patients who are to start the inhaled combination of propionic
Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device treatment
shall be informed about the study and asked for consent. Following usual practice the
patients will be followed after 6 months and after 12 months (±2 weeks) of the inhaled
treatment.
The patients' selection criteria will be according to SmPC.
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