An observational study in Chronic Obstructive Pulmonary Disease, Compliance, Patient and Quality of Life, sponsored by Elpen Pharmaceutical Co. Inc.. Completed at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Elpen Pharmaceutical Co. Inc. · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 87 studies in Pulmonary Disease, Chronic Obstructive with a site in Greece — 12 open to participants now, 16 under way, 6 of them phase 3. Pulmonary Disease, Chronic Obstructive · Greece.
Among the 87 studies in Pulmonary Disease, Chronic Obstructive with a site in Greece, this one is the 15th largest by enrollment of the 19 observational ones that give a count, is one of 3 that started in 2017, is one of 19 observational ones, and was the 49th registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →12 of the 87 studies in Pulmonary Disease, Chronic Obstructive with a site in Greece are open now. Recruiting first, the newest first:
George Papanicolaou Hospital · Sites in Greece
GlaxoSmithKline · Sites in Greece, United States, Australia and 10 more countries
Ages 40–75
Sanofi · Sites in Greece, United States, Argentina and 23 more countries
Ages 40–80
AstraZeneca · Sites in Greece, United States, Argentina and 21 more countries
Ages 40+
GlaxoSmithKline · Sites in Greece, United States, Argentina and 13 more countries
Ages 40–80
A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
87 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 600 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 979 across the 68 interventional studies, 1,000 across the 19 observational. Of the 69 that completed or were terminated, 33 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
67 of 87 have an industry lead sponsor. The 10 most frequent:
Elpen Pharmaceutical Co. Inc. is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Elpen Pharmaceutical Co. Inc. has 7 studies filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
4 of the studies in Pulmonary Disease, Chronic Obstructive with a site in Greece that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05878769Phase 3Hoffmann-La RocheA Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) | 2027-06-30 |
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07707271George Papanicolaou HospitalContinuous Versus High Intensity Interval Exercise in Chronic Obstructive Pulmonary Disease | 2027-06 |
| NCT07082738AstraZenecaA Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease | 2027-08-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 87 studies in Pulmonary Disease, Chronic Obstructive with a site in Greece, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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).
COPD patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who should be diagnosed with severe and \<60% of the expected normal rate and a history of repeated exacerbations that have significant symptoms despite regular bronchodilator therapy:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Compliance
Change in MMAS-8 item scale
Time frame: 3 months
Quality of Life
Change in CCQ scale
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Dec 2018, 12 months.
Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's 12 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →
Elpen Pharmaceutical Co. Inc. →