AdHerencE to Treatment and quAlity of Life in COPD
AdHerencE to Treatment and quAlity of Life in COPD
The present non-interventional observational study in the Greek population aims at collecting
 the characteristics of COPD patients selected to be given the inhaled combination of
 fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through
 the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance
 and the quality of life of the patients; and (b) the safety of the drugs in patients whose
 disease is treated either in a hospital or in a private physician.
Rolenium® is an inhalable combination the active ingredients of which is the inhaled
 combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg,
 (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as
 a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a
 bronchodilator less than 60% predicted) with a history of repeated seizures that have
 significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation
 of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is
 recommended4. More information on the efficacy and safety of the investigational medicinal
 product is provided in the Summary of Product Characteristics (SPC).
Inclusion Criteria:

 -  Patients to be started on Rolenium®, an inhaled combination of fluticasone propionate
 and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered
 via the Elpenhaler®

 -  Patients who should be diagnosed with severe COPD and FEV1 <60% of the expected normal
 rate and a history of repeated exacerbations that have significant symptoms despite
 regular bronchodilator therapy:

 1. Single LABA bronchoconstriction

 2. Under dual bronchoconstriction LABA / LAMA

 3. Never have received inhaled or systemic corticosteroids (ICS)

 4. Previous ICS use in the past may be present, as long as the patient is not in the
 same treatment for the last three months.

 -  Male or female patients over 18 years of age

 -  Compliance with treatment

 -  Compliance with study procedures

 -  Signed informed consent form

 Exclusion Criteria:

 -  Men or women under 18 years of age

 -  Non-compliance with treatment

 -  Inappropriate use of inhaled therapies

 -  Non-compliance in study procedures

 -  Unsigned patient consent