Status:
COMPLETED
AdHerencE to Treatment and quAlity of Life in COPD
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Compliance, Patient
Eligibility:
All Genders
18-80 years
Brief Summary
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 propionat...
Detailed Description
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 admini...
Eligibility Criteria
Inclusion
- 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:
- Single LABA bronchoconstriction
- Under dual bronchoconstriction LABA / LAMA
- Never have received inhaled or systemic corticosteroids (ICS)
- 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
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 5 2018
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03299673
Start Date
December 1 2017
End Date
December 5 2018
Last Update
November 14 2023
Active Locations (1)
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1
Evagelismos hospital
Athens, Greece