AdHerencE to Treatment and quAlity of Life in COPD

NCT ID: NCT03299673

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-05

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 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.

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 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).

Conditions

Chronic Obstructive Pulmonary Disease; Compliance, Patient; Quality of Life

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elpen Pharmaceutical Co. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evagelismos hospital

Athens, , Greece

Countries

Greece

Other Identifiers

2017-HAL-EL-75

Identifier Type: -

Identifier Source: org_study_id