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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
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief 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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease 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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Fluticasone


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


Primary Outcome Measures :
  1. Efficacy assessed by Spirometry [ Time Frame: 12 months ]
    Spirometry: Change in FEV1

  2. Efficacy assessed by MRC dyspnea questionnaire [ Time Frame: 12 months ]
    MRC Dyspnea questionnaire


Secondary Outcome Measures :
  1. Safety assessed by number of exacerbations [ Time Frame: 0,6,12 months ]
    Incidence of exacerbations

  2. Patient Satisfaction assessed by FSI-10 questionnaire [ Time Frame: 12 months ]
    FSI-10 questionnaire score per patient per study visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Nikolaos Tzanakis, MD 0030 2810.39.2224 tzanakis@med.uoc.gr

Locations
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Greece
University Hospital of Crete Recruiting
Iraklion, Crete, Greece
University Hospital of Herakleion Recruiting
Irákleion, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
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Study Chair: Nikolaos Tzanakis, MD University of Herakleion, Crete

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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT02978703     History of Changes
Other Study ID Numbers: 2016-HAL-EL-67
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents