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

NCT02978703 | Completed DMC

• 1 other identifier: 2016-HAL-EL-67
• Study Type: observational
• Target: 1,730
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Efficacy assessed by Spirometry

  Spirometry: Change in FEV1

  12 months

• Efficacy assessed by MRC dyspnea questionnaire

  MRC Dyspnea questionnaire

  12 months

Secondary Outcomes (2)

• Safety assessed by number of exacerbations

  0,6,12 months

• Patient Satisfaction assessed by FSI-10 questionnaire

  12 months

Interventions

COPD Pharmacologic Substance DRUG

COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (2)

University Hospital of Crete

Heraklion, Crete, Greece

Location

University Hospital of Herakleion

Heraklion, Greece

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolaos Tzanakis, MD

  University of Herakleion, Crete

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 1, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 13, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)