Chronic Obstructive Pulmonary DiseaseAEOLOSNCT02978703
EvAluation of Clinical Effectiveness Of RoLenium Administered With Elpenhaler in Chronic Obstructive Pulmonary Disease (COPD) patientS in Daily Clinical Practice, in Greece
An observational study of Chronic Obstructive Pulmonary Disease, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.
Trial summary
Observational study for the evaluation of clinical effectiveness in daily clinical practice of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg - Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50%… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD Pharmacologic Substance
- How many people
- 1,730 participants
- Where
- 2 sitesGreece
- Study dates
- Jan 2017to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients will be recruited in the study. The patients will be diagnosed with COPD with a FEV1 <50% predicted normal (pre-bronchodilator) in need of symptomatic treatment and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. The study will be conducted in about 100 sites in Greece. 5 study sites will be Hospitals and 75 study sites will be pulmonologists in private practice. The investigators will be Pulmonologists. Patients that are to start treatment with the inhaled combination of propionic Fluticazone and Salmeterol in doses (250+50)mcg, (500+50)mcg are eligible for inclusion in the study. In accordance with the approved labelling these patients should:
Who may be able to join
- patients selected for treatment with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device
- FEV1 <50% predicted normal (pre-bronchodilator),
- a history of repeated exacerbations who have significant symptoms despite regular bronchodilator therapy treated in Hospital outpatient specialist ward settings, in the daily clinical practice
- have signed informed consent
- be compliant with study procedures
Who cannot join
- - patients not selected for treatment with the inhaled combination of propionic
- FEV1 >50% predicted normal (pre-bronchodilator),
- no history of repeated exacerbations
- not signed informed consent
- will not be compliant with study procedures
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
University Hospital of Crete
Heraklion, Crete
University Hospital of Herakleion
Heraklion
About this study
Official title: Non Interventional, Observational, Multi-center Study to Evaluate the Efficacy and Safety of Fluticasone/Salmeterol (Rolenium / Elpenhaler Administration in Greek COPD Pattients
Observational study for the evaluation of clinical effectiveness in daily clinical practice of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg - Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy in Greece.
Read the detailed description
The scientific Objectives are to study in the Greek population the real-life patient characteristics of patients selected for treatment with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device and the performance of this inhaled combination in terms of effectiveness and safety in approximately 2500 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy treated in Hospital and outpatient specialist ward settings, in the daily clinical practice
The primary endpoints for the study are:
- Change in FEV1, FVC, FEV1/FVC from baseline to 12 months (±2 weeks) from starting taking Rolenium®.
The Secondary endpoints for the study are:
- Change in lung function parameters from baseline to month 6 (±2 weeks) from start of Rolenium® treatment
- Incidence and frequency of exacerbations
- Hospitalizations due to COPD exacerbation
- Change in MRC Dyspnea index.
- Patient's satisfaction with the use of Elpenhaler device assessed with FSI 10 Questionnaire after 6 months and after 12 months (±2 weeks).
- Concomitant administration of inhaled bronchodilators
- ADRs during the treatment period (only via the post-marketing procedure). Methodology The study will be a purely observational, prospective study, collecting data on patient treated with the inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device in Greece without any interference with the treatment practices of the physicians involved in the data collection. Thus patients will only be considered for inclusion after the decision has been taken to treat them with inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg administered with Elpenhaler device and no visits, diagnostic procedures or monitoring will take place which would not happen had the patient not been included in the study. This means that only data generated in usual daily clinical practice will be collected in the study, so that no extra examinations or study visits will take place due to the study. The study will not be comparative; only inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg,- administered with Elpenhaler device will be included. Consecutive patients who are to start the inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device treatment shall be informed about the study and asked for consent. Following usual practice the patients will be followed after 6 months and after 12 months (±2 weeks) of the inhaled treatment.
The patients' selection criteria will be according to SmPC.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD Pharmacologic Substance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD Pharmacologic SubstanceDrug
COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessed by Spirometry
Spirometry: Change in FEV1
Measured: 12 months
Efficacy assessed by MRC dyspnea questionnaire
MRC Dyspnea questionnaire
Measured: 12 months
Secondary outcomes (2)
Safety assessed by number of exacerbations
Incidence of exacerbations
Measured: 0,6,12 months
Patient Satisfaction assessed by FSI-10 questionnaire
FSI-10 questionnaire score per patient per study visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikolaos Tzanakis, MD, Study chair, University of Herakleion, Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978703
- Sponsor's protocol ID
- 2016-HAL-EL-67
- Acronym
- AEOLOS
- Status last verified
- Jan 2018
- First submitted
- 16 Nov 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional, Observational, Multi-center Study to Evaluate the Efficacy and Safety of Fluticasone/Salmeterol (Rolenium / Elpenhaler Administration in Greek COPD Pattients
- ClinicalTrials.gov ID
- NCT02978703
- Acronym / sponsor ID
- AEOLOS / 2016-HAL-EL-67
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,730 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study for the evaluation of clinical effectiveness in daily clinical practice of inhaled combination of propionic Fluticasone and Salmeterol in doses (500+50)mcg - Rolenium- administered with Elpenhaler device in approximately 2000 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy in Greece.
Detailed description
The scientific Objectives are to study in the Greek population the real-life patient characteristics of patients selected for treatment with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device and the performance of this inhaled combination in terms of effectiveness and safety in approximately 2500 COPD (Chronic Obstructive Pulmonary Disease) patients with a FEV1 <50% predicted normal (pre-bronchodilator), a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy treated in Hospital and outpatient specialist ward settings, in the daily clinical practice
The primary endpoints for the study are:
- Change in FEV1, FVC, FEV1/FVC from baseline to 12 months (±2 weeks) from starting taking Rolenium®.
The Secondary endpoints for the study are:
- Change in lung function parameters from baseline to month 6 (±2 weeks) from start of Rolenium® treatment
- Incidence and frequency of exacerbations
- Hospitalizations due to COPD exacerbation
- Change in MRC Dyspnea index.
- Patient's satisfaction with the use of Elpenhaler device assessed with FSI 10 Questionnaire after 6 months and after 12 months (±2 weeks).
- Concomitant administration of inhaled bronchodilators
- ADRs during the treatment period (only via the post-marketing procedure). Methodology The study will be a purely observational, prospective study, collecting data on patient treated with the inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device in Greece without any interference with the treatment practices of the physicians involved in the data collection. Thus patients will only be considered for inclusion after the decision has been taken to treat them with inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg administered with Elpenhaler device and no visits, diagnostic procedures or monitoring will take place which would not happen had the patient not been included in the study. This means that only data generated in usual daily clinical practice will be collected in the study, so that no extra examinations or study visits will take place due to the study. The study will not be comparative; only inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg,- administered with Elpenhaler device will be included. Consecutive patients who are to start the inhaled combination of propionic Fluticasone and Salmeterol (500+50) mcg,- administered with Elpenhaler device treatment shall be informed about the study and asked for consent. Following usual practice the patients will be followed after 6 months and after 12 months (±2 weeks) of the inhaled treatment.
The patients' selection criteria will be according to SmPC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients will be recruited in the study. The patients will be diagnosed with COPD with a FEV1 <50% predicted normal (pre-bronchodilator) in need of symptomatic treatment and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. The study will be conducted in about 100 sites in Greece. 5 study sites will be Hospitals and 75 study sites will be pulmonologists in private practice. The investigators will be Pulmonologists. Patients that are to start treatment with the inhaled combination of propionic Fluticazone and Salmeterol in doses (250+50)mcg, (500+50)mcg are eligible for inclusion in the study. In accordance with the approved labelling these patients should:
Key inclusion criteria (5 listed)
- patients selected for treatment with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device
- FEV1 <50% predicted normal (pre-bronchodilator),
- a history of repeated exacerbations who have significant symptoms despite regular bronchodilator therapy treated in Hospital outpatient specialist ward settings, in the daily clinical practice
- have signed informed consent
- be compliant with study procedures
Key exclusion criteria (5 listed)
- - patients not selected for treatment with the inhaled combination of propionic
- FEV1 >50% predicted normal (pre-bronchodilator),
- no history of repeated exacerbations
- not signed informed consent
- will not be compliant with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD Pharmacologic SubstanceCOPD patients treated by Fluticasone / Salmetrol via Elpenhaler device | Drug | – |
Primary outcome
Efficacy assessed by Spirometry
Time frame: 12 months
Spirometry: Change in FEV1
Efficacy assessed by MRC dyspnea questionnaire
Time frame: 12 months
MRC Dyspnea questionnaire
2 secondary outcomes
Safety assessed by number of exacerbations
Time frame: 0,6,12 months
Patient Satisfaction assessed by FSI-10 questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Tzanakis, MD study chair
University of Herakleion, Crete
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessed by Spirometry (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.