Overview

EvAluation of Clinical Effectiveness Of RoLenium Administered With Elpenhaler in Chronic Obstructive Pulmonary Disease (COPD) patientS in Daily Clinical Practice, in Greece

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Treatments:
Fluticasone
Criteria
Inclusion Criteria:

- patients selected for treatment with the inhaled combination of propionic Fluticasone
and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device

- FEV1 <50% predicted normal (pre-bronchodilator),

- a history of repeated exacerbations who have significant symptoms despite regular
bronchodilator therapy treated in Hospital outpatient specialist ward settings, in the
daily clinical practice

- have signed informed consent

- be compliant with study procedures

Exclusion Criteria:

- - patients not selected for treatment with the inhaled combination of propionic

- FEV1 >50% predicted normal (pre-bronchodilator),

- no history of repeated exacerbations

- not signed informed consent

- will not be compliant with study procedures