ClinicalTrials.gg
CompletedNCT03300076COMPLETEUpdated Dec 5, 2018

COMPLliancE and qualiTy of lifE in Asthma

An observational study in Asthma, 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 2018-12-05.

Sponsored by Elpen Pharmaceutical Co. Inc. · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 57 studies in Asthma with a site in Greece — 9 open to participants now, 13 under way, 5 of them phase 3. Asthma · Greece.

Enrollment
7th of 18
800 · median 426
Started
2018
with 4 others
Observational
18 of 57
2 open now
Registered
25th of 57
by date
Lead sponsor
7 of 57
Elpen Pharmaceutical Co. Inc.

Among the 57 studies in Asthma with a site in Greece, this one is the 7th largest by enrollment of the 18 observational ones that give a count, is one of 5 that started in 2018, is one of 18 observational ones, and was the 25th registered.

Asthma

4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.

Browse Asthma studies →

Open to participants now

9 of the 57 studies in Asthma with a site in Greece are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

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 →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

A multicenter, open, non-interventional, prospective, clinical observational study on Conformity to Therapy and Quality of Life in Asthma in patients living in Greece

Read the detailed description

Dry powder devices, available since 1970, have been developed to make inhalation simpler than pMDIs and relieve the need for co-ordination of spraying and inhalation, which is particularly important for patient groups such as the elderly and children. In addition, dry powder devices do not contain propellant gases potentially hostile to the environment as they are activated by inhalation of the patient and do not cause cold sensation upon inhalation.

Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an inhaler is the basic treatment for asthma6.

The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:

  • Improves the symptoms,
  • Reduces nightly asthma symptoms,
  • Improves pulmonary function,
  • Reduces the use of β2-agonists for rapid action,
  • Reduces the number of seizures,
  • Does not increase the risk of hospitalizations due to asthma,
  • Achieves clinical asthma control in more patients, faster and with less ICS than would be required if ICS were administered alone.

The greater effectiveness of combination therapy has led to the development of stable combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol, budesonide-formoterol stable compounds) are concomitantly conveyed.

Stable combinations are more user-friendly for patients, potentially increasing compliance, and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations available, the budesonide-formoterol combination can be used both as maintenance therapy and symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components of the budesonide-formoterol combination when administered are helpful in enhancing protection from severe seizures in patients receiving combination therapy for maintenance and improve the control of asthma at relatively low ICS doses.

03

Conditions studied

  • Asthma
  • Compliance, Patient
  • Quality of Life
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Asthmatic adult 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.

Inclusion criteria

  • Male or female asthma patients over 18 years of age
  • Compliance with treatment
  • Compliance with study procedures
  • Signed form
  • Patients not satisfactorily controlled with inhaled and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:

    1. Patients receiving ICS inhaled and SABA invoked
    2. Patients receiving inhaled ICS and LABA with separate devices each
    3. Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month
    4. Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA

Exclusion criteria

Exclusion Criteria:

  • Male or female asthma patients under 18 years of age
  • Unsigned patient consent
  • Non-compliance with treatment
  • Non-compliance in study procedures
  • patients (at any stage)
Terms in these criteria, in plain language(3)

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.

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.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Quality of Life

    Change in mini AQLQ scale

    Time frame: 6 months

Secondary outcomes

  1. Compliance

    Change in MMAS-8 scale

    Time frame: 6 months

07

Study locations

1 site
  • Sotiria Pulmonary Hospital
    Athens, Greece
08

References and documents

Publications

  • Exarchos KP, Rovina N, Krommidas G, Latsios D, Gogali A, Kostikas K. Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study. BMC Pulm Med. 2022 Jun 27;22(1):254. doi: 10.1186/s12890-022-02049-0. Erratum In: BMC Pulm Med. 2022 Aug 23;22(1):322. doi: 10.1186/s12890-022-02117-5. PubMed 35761234 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Dec 2018, 10 months.

Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 10 months is below that.

Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2017
First posted
Oct 3, 2017
StartActual
Feb 1, 2018
Primary completionActual
Dec 1, 2018
CompletionActual
Dec 1, 2018
Last update
Dec 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03300076
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Feb 1, 2018
Primary completion
Dec 1, 2018
Completion
Dec 1, 2018
Last update
Dec 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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