Clinical trial NCT03299673: AdHerencE to Treatment and quAlity of Life in COPD
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Compliance, Patient
Quality of Life
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients

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).

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

Primary outcomes:
measure: Compliance
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evagelismos hospital
Study officials:
References: