AdHerencE to Treatment and quAlity of Life in COPD (AHEAD)

Observational Study to Investigate the Compliance of Patients With COPD With the 8-item Morisky Medication Adherence Scale and Assessing the Quality of Life of Patients as Shown by the Clinical COPD Questionnaire (CCQ) Questionnaire.

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Evagelismos hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COPD patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Change in MMAS-8 item scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Change in CCQ scale	3 months

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 5, 2018
• Study Completion (Actual): December 5, 2018

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2017-HAL-EL-75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No