AsthmaNCT00986219
A Study for the Assessment of the Words Used by Patients and Physicians to Express Asthma Symptoms
An observational study of Asthma, run by AstraZeneca at 40 sites in Greece.
Trial summary
The purpose of the study is to evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 696 participants
- Where
- 40 sitesGreece
- Study dates
- Sep 2009to Dec 2009
- 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 patients with persistent asthma treated with inhaled corticosteroid-based maintenance treatment for at least 6 months and followed up by thep hysician for at least the same period of time.
Who may be able to join
- Diagnosis of persistent asthma treated with inhaled corticosteroid-based maintenance treatment for at least 6 months and followed up by the investigator for at least the same period of time
Who cannot join
- Patient with a cardiac disease (congestive heart failure, coronary heart disease)
- Patient with a respiratory disease other than asthma (COPD, sleep apnoea syndrome)
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Greece40 sites
Research Site
Agrinio, Aitoloakarnanias
Research Site
Amfisa, Fokidos
Research Site
Argos, Argolida
Research Site
Arta, Artas
Research Site
Athens, Attica
Research Site
Chalcis, Chalkida
Research Site
Chalkidiki, Chalkidiki
Research Site
Chania, Crete
Research Site
Chrisoupoli, Kavalas
Research Site
Drama, Drammas
Research Site
Edessa, Pella
Research Site
Ermoupoli, Cyclades
Research Site
Farsala, Larrisa
Research Site
Heraklion, Crete
Research Site
Igoumenitsa, Thesprotia
Research Site
Ioannina, Ioanninon
Research Site
Kalamata, Messinia
Research Site
Karditsa, Karditsis
Research Site
Kastoria, Florinas
Research Site
Katerini, Peierias
Research Site
Kavala, Kavalas
Research Site
Komotini, Rodopi
Research Site
Ksanthi, Ksanthis
Research Site
Lakonia, Lakonia
Research Site
Larissa, Larisas
Research Site
Livadia, Biotias
Research Site
Loutraki, Korinthia
Research Site
Naupaktos, Aitoloakarnania
Research Site
Pátrai, Achaia
Research Site
Peraious, Attica
Research Site
Pírgos, Ilia
Research Site
Ptolemaida, Kozani
Research Site
Rethymno, Crete
Research Site
Rhodes, Dodekanisou
Research Site
Serres, Serron
Research Site
Thérmo, Aitoloakarnanias
Research Site
Thessaloniki, Thessalonikis
Research Site
Trikala, Trikalon
Research Site
Véroia, Imathia
Research Site
Volos, Magnisia
About this study
Official title: A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express Asthma Symptoms and the Limitations of Daily Activities in Primary Care. The " Asthma Language " Survey
The purpose of the study is to evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma.
- Conditions
- Asthma
- Keywords
- Asthma, Language, Symptoms,, Limitation of Daily activities, Patients, Physicians, Greece
- Medical subject headings
- Asthma, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Language between patients and physicians | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma
Measured: Day 1
Secondary outcomes (3)
The most frequently used words (lexical intensity) by the patient and the physician to express asthma symptoms and the limitations of daily activities.
Measured: Day 1
The concordance of words used by physicians and patients according to the level of asthma control (as assessed by ACQ).
Measured: Day 1
The actions recommended by the physician or those initiated by the patient and are associated with words that express symptoms.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mina Gaga, MD, Principal investigator, Director of the 7th Respiratory Clinic, Sotiria Hospital, Athens, GreecePanagiotis Pontikis, Dr., Study director, Marketing Company Medical Director, AstraZeneca Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986219
- Sponsor's protocol ID
- NIS-RGR-DUM-2009/1
- Status last verified
- Dec 2009
- First submitted
- 22 Sep 2009
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express Asthma Symptoms and the Limitations of Daily Activities in Primary Care. The " Asthma Language " Survey
- ClinicalTrials.gov ID
- NCT00986219
- Acronym / sponsor ID
- NIS-RGR-DUM-2009/1
- Conditions
- Asthma
- Keywords
- Asthma, Language, Symptoms,, Limitation of Daily activities, Patients, Physicians, Greece
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Sep 2009 (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.
The purpose of the study is to evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Language between patients and physicians | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care patients with persistent asthma treated with inhaled corticosteroid-based maintenance treatment for at least 6 months and followed up by thep hysician for at least the same period of time.
Key inclusion criteria (1 listed)
- Diagnosis of persistent asthma treated with inhaled corticosteroid-based maintenance treatment for at least 6 months and followed up by the investigator for at least the same period of time
Key exclusion criteria (2 listed)
- Patient with a cardiac disease (congestive heart failure, coronary heart disease)
- Patient with a respiratory disease other than asthma (COPD, sleep apnoea syndrome)
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
The concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma
Time frame: Day 1
3 secondary outcomes
The most frequently used words (lexical intensity) by the patient and the physician to express asthma symptoms and the limitations of daily activities.
Time frame: Day 1
The concordance of words used by physicians and patients according to the level of asthma control (as assessed by ACQ).
Time frame: Day 1
The actions recommended by the physician or those initiated by the patient and are associated with words that express symptoms.
Time frame: Day 1
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 17 Dec 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.
Mina Gaga, MD principal investigator
Director of the 7th Respiratory Clinic, Sotiria Hospital, Athens, Greece
Panagiotis Pontikis, Dr. study director
Marketing Company Medical Director, AstraZeneca Greece
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 40 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 1 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 17 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
The concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma (time frame: Day 1). 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 17 Dec 2009.