EvAluation of Clinical Effectiveness Of RoLenium Administered With Elpenhaler in Chronic Obstructive Pulmonary Disease (COPD) patientS in Daily Clinical Practice, in Greece (AEOLOS)
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|ClinicalTrials.gov Identifier: NCT02978703|
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease||Drug: COPD Pharmacologic Substance|
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|
|Estimated Enrollment :||2000 participants|
|Official Title:||Non Interventional, Observational, Multi-center Study to Evaluate the Efficacy and Safety of Fluticasone/Salmeterol (Rolenium / Elpenhaler Administration in Greek COPD Pattients|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Drug: COPD Pharmacologic Substance
COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device
- Efficacy assessed by Spirometry [ Time Frame: 12 months ]Spirometry: Change in FEV1
- Efficacy assessed by MRC dyspnea questionnaire [ Time Frame: 12 months ]MRC Dyspnea questionnaire
- Safety assessed by number of exacerbations [ Time Frame: 0,6,12 months ]Incidence of exacerbations
- Patient Satisfaction assessed by FSI-10 questionnaire [ Time Frame: 12 months ]FSI-10 questionnaire score per patient per study visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978703
|Contact: Nikolaos Tzanakis, MD||0030 firstname.lastname@example.org|
|University Hospital of Crete||Recruiting|
|Iraklion, Crete, Greece|
|University Hospital of Herakleion||Recruiting|
|Study Chair:||Nikolaos Tzanakis, MD||University of Herakleion, Crete|