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OpenTrials
Completed

NCT Number: NCT03299673

AdHerencE to Treatment and quAlity of Life in COPD

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Primary outcomes

  1. Compliance

    Time frame: 3 months

    Change in MMAS-8 item scale

Secondary outcomes

  1. Quality of Life

    Time frame: 3 months

    Change in CCQ scale

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study 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.

Acronym: AHEAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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