EvAluation of Clinical Effectiveness Of RoLenium Administered With Elpenhaler in Chronic Obstructive Pulmonary Disease (COPD) patientS in Daily Clinical Practice, in Greece
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

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.
    

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.
    

Intervention name(s): COPD Pharmacologic Substance
Intervention type(s): Drug
Intervention description(s): COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device
Observational model: Other
Time perspective: Prospective
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: