AsthmaNCT00573222
Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma
An observational study of Asthma, run by AstraZeneca at 13 sites in Croatia.
Trial summary
This is a 3-month non-interventional, observational study on patients with moderate and severe asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort
- How many people
- 330 participants
- Where
- 13 sitesCroatia
- Study dates
- Nov 2007to May 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: pulmonology clinics
Who may be able to join
- Patients with moderate and severe asthma on Symbicort SMART treatment
Who cannot join
- Under 18 years old
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Croatia13 sites
Research Site
Čakovec
Research Site
Dubrovnik
Research Site
Osijek
Research Site
Požega
Research Site
Pula
Research Site
Rijeka
Research Site
Senj
Research Site
Šibenik
Research Site
Slavonskibrod
Research Site
Vinkovci
Research Site
Vukovar
Croatia
Zadar
Research Site
Zagreb
About this study
This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.
- Conditions
- Asthma
- Being tested
- Symbicort
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbicortDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate & describe asthma control in adult patients w/moderate to severe asthma treated w/Symbicort SMART following the frequency, type & severity of symptoms through the Asthma Control Questionnaire.
Secondary outcomes (1)
to evaluate the safety of Symbicort SMART treatment through the number and type of reported adverse events 2. assessment of patient's satisfaction with the treatment 3.assessment of physician's satisfaction with the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
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
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anan Marija Gjurovic, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573222
- Sponsor's protocol ID
- NIS-RHR-SYM-2007/1
- Status last verified
- Nov 2010
- First submitted
- 13 Dec 2007
- Last updated
- 1 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma
- ClinicalTrials.gov ID
- NCT00573222
- Acronym / sponsor ID
- NIS-RHR-SYM-2007/1
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Dec 2007 (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.
This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pulmonology clinics
Key inclusion criteria (1 listed)
- Patients with moderate and severe asthma on Symbicort SMART treatment
Key exclusion criteria (1 listed)
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symbicort | Drug | – |
Primary outcome
To evaluate & describe asthma control in adult patients w/moderate to severe asthma treated w/Symbicort SMART following the frequency, type & severity of symptoms through the Asthma Control Questionnaire.
1 secondary outcome
to evaluate the safety of Symbicort SMART treatment through the number and type of reported adverse events 2. assessment of patient's satisfaction with the treatment 3.assessment of physician's satisfaction with the treatment
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 1 Dec 2010.
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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.
Anan Marija Gjurovic study director
AstraZeneca
13 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 13 sites in Croatia.
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 1 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 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Croatia. 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?
To evaluate & describe asthma control in adult patients w/moderate to severe asthma treated w/Symbicort SMART following the frequency, type & severity of symptoms through the Asthma Control Questionnaire.. 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 1 Dec 2010.