AsthmaCOMPLETENCT03300076
COMPLliancE and qualiTy of lifE in Asthma
An observational study of Asthma and Compliance, Patient, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma, Compliance, Patient, Quality of Life
- How many people
- 800 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2018to 1 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: Asthmatic adult patients
Who may be able to join
- Male or female asthma patients over 18 years of age
- Compliance with treatment
- Compliance with study procedures
- Signed informed consent form
- Patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:
- Patients receiving ICS inhaled and SABA invoked
Show all 9Show fewer
- Patients receiving inhaled ICS and LABA with separate devices each
- Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month
- Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA
Who cannot join
- Male or female asthma patients under 18 years of age
- Unsigned patient consent
- Non-compliance with treatment
- Non-compliance in study procedures
- COPD patients (at any stage)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients
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.
- Conditions
- Asthma, Compliance, Patient, Quality of Life
- Medical subject headings
- Asthma, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Change in mini AQLQ scale
Measured: 6 months
Secondary outcomes (1)
Compliance
Change in MMAS-8 scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Feb 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300076
- Sponsor's protocol ID
- 2017-HAL-EL-74
- Acronym
- COMPLETE
- Status last verified
- Mar 2018
- First submitted
- 28 Sep 2017
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35761234
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients
- ClinicalTrials.gov ID
- NCT03300076
- Acronym / sponsor ID
- COMPLETE / 2017-HAL-EL-74
- Conditions
- Asthma, Compliance, Patient, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- 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.
A multicenter, open, non-interventional, prospective, clinical observational study on Conformity to Therapy and Quality of Life in Asthma in patients living in Greece
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.
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
- Asthmatic adult patients
Key inclusion criteria (9 listed)
- Male or female asthma patients over 18 years of age
- Compliance with treatment
- Compliance with study procedures
- Signed informed consent form
- Patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:
Key exclusion criteria (5 listed)
- Male or female asthma patients under 18 years of age
- Unsigned patient consent
- Non-compliance with treatment
- Non-compliance in study procedures
- COPD patients (at any stage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life
Time frame: 6 months
Change in mini AQLQ scale
1 secondary outcome
Compliance
Time frame: 6 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 5 Dec 2018.
- Derived from this study: PubMed 35761234Exarchos 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Compliance, Patient, run by Elpen Pharmaceutical Co. Inc. at 1 site 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 9 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300076, which also lists 1 linked publication.
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 5 Dec 2018.