AdHerencE to Treatment and quAlity of Life in COPD

Completed

• Conditions: Quality of Life; Chronic Obstructive Pulmonary Disease; Compliance, Patient

• Registration Number: NCT03299673
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

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).

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-03
• Study Start: 2017-12-01
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance	3 months	Change in MMAS-8 item scale

Secondary Outcome Measures

Name	Time	Method
Quality of Life	3 months	Change in CCQ scale

Trial Locations

Locations (1)

Evagelismos hospital; 🇬🇷 Athens, Greece