AdHerencE to Treatment and quAlity of Life in COPD

Quality of Life Clinical Trial

— AHEAD  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299673
• Other study ID #: 2017-HAL-EL-75
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 5, 2018

Study information

• Verified date: November 2023
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 5, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Compliance, Patient
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Quality of Life

Locations

Country	Name	City	State
Greece	Evagelismos hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Change in MMAS-8 item scale	3 months
Secondary	Quality of Life	Change in CCQ scale	3 months