EvAluation of Clinical Effectiveness Of RoLenium Administered With Elpenhaler in Chronic Obstructive Pulmonary Disease (COPD) patientS in Daily Clinical Practice, in Greece
NCT02978703 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1730
Last updated 2019-05-13
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.
Conditions
Interventions
- DRUG
-
COPD Pharmacologic Substance
COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device
Sponsors & Collaborators
-
Elpen Pharmaceutical Co. Inc.
lead INDUSTRY
Principal Investigators
-
Nikolaos Tzanakis, MD · University of Herakleion, Crete
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- Greece
Study Locations
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