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

Chronic Obstructive Pulmonary Disease Clinical Trial

— AEOLOS  

Official title:

Non Interventional, Observational, Multi-center Study to Evaluate the Efficacy and Safety of Fluticasone/Salmeterol (Rolenium / Elpenhaler Administration in Greek COPD Pattients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978703
• Other study ID #: 2016-HAL-EL-67
• Status: Completed
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1730
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• COPD Pharmacologic Substance
COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device

Locations

Country	Name	City	State
Greece	University Hospital of Herakleion	Irákleion
Greece	University Hospital of Crete	Iraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy assessed by Spirometry	Spirometry: Change in FEV1	12 months
Primary	Efficacy assessed by MRC dyspnea questionnaire	MRC Dyspnea questionnaire	12 months
Secondary	Safety assessed by number of exacerbations	Incidence of exacerbations	0,6,12 months
Secondary	Patient Satisfaction assessed by FSI-10 questionnaire	FSI-10 questionnaire score per patient per study visit	12 months