AdHerencE to Treatment and quAlity of Life in COPD

NCT03299673 | Completed

• 1 other identifier: 2017-HAL-EL-75
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Compliance

  Change in MMAS-8 item scale

  3 months

Secondary Outcomes (1)

• Quality of Life

  3 months

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Evagelismos hospital

Athens, Greece

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Patient Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: December 1, 2017
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

GR (1)