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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: COPD Pharmacologic Substance

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1730

Contacts and Locations

Study Locations

• Greece
  • Irákleion, Greece
    • University Hospital of Herakleion
  • Crete
    • Iraklion, Crete, Greece
      • University Hospital of Crete

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients will be recruited in the study. The patients will be diagnosed with COPD with a FEV1 <50% predicted normal (pre-bronchodilator) in need of symptomatic treatment and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

The study will be conducted in about 100 sites in Greece. 5 study sites will be Hospitals and 75 study sites will be pulmonologists in private practice.

The investigators will be Pulmonologists.

Patients that are to start treatment with the inhaled combination of propionic Fluticazone and Salmeterol in doses (250+50)mcg, (500+50)mcg are eligible for inclusion in the study. In accordance with the approved labelling these patients should:

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy assessed by Spirometry	Spirometry: Change in FEV1	12 months
Efficacy assessed by MRC dyspnea questionnaire	MRC Dyspnea questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by number of exacerbations	Incidence of exacerbations	0,6,12 months
Patient Satisfaction assessed by FSI-10 questionnaire	FSI-10 questionnaire score per patient per study visit	12 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.
• Investigators: Study Chair: Nikolaos Tzanakis, MD, University of Herakleion, Crete

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (ESTIMATE): December 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2016-HAL-EL-67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO