New StrategiesEPAGGELIANCT00695357
Opinion of Patients Under Treatment That Meets the Criteria of New Treatment Strategy According to GINA 2006
An observational study of New Strategies and GINA 2006, run by AstraZeneca at 31 sites in Greece.
Trial summary
Cross-sectional, one visit study. All the data will be collected through questionnaires. Descriptives statistics will be applied to the data. 832 patients will participate to the study and 104 physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Strategies, GINA 2006, Patient Opinion
- How many people
- 832 participants
- Where
- 31 sitesGreece
- Study dates
- Apr 2008to Jun 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care
Who may be able to join
- Patients diagnosed with persistent asthma (GINA 2005) for at least 6 months before entering the study
- Patients who are under treatment according to the new strategies described in GINA 2006 for at least 3 months before entering the study
Who cannot join
- Patients who are not willing to sign the Informed Consent Form
- COPD Patients
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Greece31 sites
Research Site
Aleksandroupoli
Research Site
Amaliáda
Research Site
Argos
Research Site
Arta
Research Site
Athens
Research Site
Chania
Research Site
Drama
Research Site
Githio
Research Site
Goúnari
Research Site
Heraklion
Research Site
Imathia
Research Site
Ioannina
Research Site
Kalamata
Research Site
Katerini
Research Site
Kavala
Research Site
Komotini
Research Site
Lamia
Research Site
Larissa
Research Site
Nafpaktos
Research Site
Neapoli
Research Site
Pátrai
Research Site
Pírgos
Research Site
Rafina
Research Site
Serres
Research Site
Sparti
Research Site
Thessaloniki
Research Site
Trikala
Research Site
Tripoli
Research Site
Véria
Research Site
Volos
Research Site
Xalkida
About this study
Cross-sectional, one visit study. All the data will be collected through questionnaires. Descriptives statistics will be applied to the data. 832 patients will participate to the study and 104 physicians.
- Conditions
- New Strategies, GINA 2006, Patient Opinion
- Keywords
- Asthma treatment, GINA 2006, patient perception
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of Asthma treatment satisfaction and control grading
Measured: single visit / once
Secondary outcomes (2)
Rate of treatment compliance
Measured: single visit / once
Patients quality of life under treatment
Measured: single visit / once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New StrategiesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zachariadis Manolis, MD, Principal investigator, Euroclinic, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695357
- Sponsor's protocol ID
- NIS-RGR-DUM-2008/1
- Acronym
- EPAGGELIA
- Status last verified
- Apr 2009
- First submitted
- 9 Jun 2008
- Last updated
- 30 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opinion of Patients Under Treatment That Meets the Criteria of New Treatment Strategy According to GINA 2006
- ClinicalTrials.gov ID
- NCT00695357
- Acronym / sponsor ID
- EPAGGELIA / NIS-RGR-DUM-2008/1
- Conditions
- New Strategies, GINA 2006, Patient Opinion
- Keywords
- Asthma treatment, GINA 2006, patient perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 832 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Jun 2008 (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.
Cross-sectional, one visit study. All the data will be collected through questionnaires. Descriptives statistics will be applied to the data. 832 patients will participate to the study and 104 physicians.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care
Key inclusion criteria (2 listed)
- Patients diagnosed with persistent asthma (GINA 2005) for at least 6 months before entering the study
- Patients who are under treatment according to the new strategies described in GINA 2006 for at least 3 months before entering the study
Key exclusion criteria (2 listed)
- Patients who are not willing to sign the Informed Consent Form
- COPD Patients
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
Percentage (%) of Asthma treatment satisfaction and control grading
Time frame: single visit / once
2 secondary outcomes
Rate of treatment compliance
Time frame: single visit / once
Patients quality of life under treatment
Time frame: single visit / once
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 30 Apr 2009.
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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.
Zachariadis Manolis, MD principal investigator
Euroclinic, Athens, Greece
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Strategies and GINA 2006, run by AstraZeneca at 31 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 2 inclusion and 2 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 30 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
Percentage (%) of Asthma treatment satisfaction and control grading (time frame: single visit / once). 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 30 Apr 2009.