AsthmaNCT00884689
A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®
An observational study of Asthma, run by AstraZeneca at 43 sites in Germany.
Trial summary
The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 500 participants
- Where
- 43 sitesGermany
- Study dates
- Apr 2009to Jun 2010
- 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: Asthma treatment will not be assigned randomly, but will be administered at the discretion of the physicians according to standard medical practice. Each site should enrol 5 patients using the Symbicort® SMART® principle and 5 patients being prescribed a free combination GCS / LABA treatment.
Who may be able to join
- Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
- Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
- A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
- A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:
- Oral/systemic GCS treatment due to asthma for at least 3 days
- Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS
Who cannot join
- Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
- Use of ß-blocking agents
- Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Germany43 sites
Research Site
Aschaffenburg
Research Site
Bad Lippspringe
Research Site
Bad Sassendorf
Research Site
Bergkamen
Research Site
Berlin
Research Site
Bochum
Research Site
Bonn
Research Site
Braunschweig
Research Site
Buchholz
Research Site
Chemnitz
Research Site
Coswig
Research Site
Cottbus
Research Site
Dortmund
Research Site
Dresden
Research Site
Düsseldorf
Research Site
Frankfurt
Research Site
Fürth
Research Site
Gelsenkirchen
Research Site
Gütersloh
Research Site
Halle
Research Site
Hamburg
Research Site
Ketzin
Research Site
Köthen
Research Site
Leipzig
Research Site
Löhne
Research Site
Lübeck
Research Site
Lüdenscheid
Research Site
Marburg
Research Site
Marl
Research Site
Mittelbach
Research Site
Mühlhausen
Research Site
Mülheim
Research Site
München
Research Site
Oschersleben
Research Site
Potsdam
Research Site
Remscheid
Research Site
Saarlouis
Research Site
Schwetzingen
Research Site
Steinhagen
Research Site
Stockach
Research Site
Wedel
Research Site
Wesseling
Research Site
Weyhe
About this study
Official title: A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.
The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.
- Conditions
- Asthma
- Keywords
- Symbicort SMART, Free Combination GCS/LABA treatment
- Medical subject headings
- Asthma
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 |
|---|---|---|
| 1 | Asthma patient with specific treatment | |
| 2 | Asthma patient on different specific treatment compared to the other group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of rescue medication
Measured: daily during 6 month
Secondary outcomes (3)
Quality of life
Measured: 3 times during study
Efficacy variables
Measured: during 6 month
Safety variables
Measured: during 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Study completionJun 2010
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
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinResearch, GmbH
- Investigators
- Kai Richter, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884689
- Sponsor's protocol ID
- NIS-RDE-SYM-2009/1
- Status last verified
- Mar 2011
- First submitted
- 20 Apr 2009
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.
- ClinicalTrials.gov ID
- NCT00884689
- Acronym / sponsor ID
- NIS-RDE-SYM-2009/1
- Conditions
- Asthma
- Keywords
- Symbicort SMART, Free Combination GCS/LABA treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- ClinResearch, GmbH
- Study start
- Apr 2009
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Apr 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 this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.
Study design
- Observational model
- Case only
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Asthma patient with specific treatment |
| 2 | – | –Asthma patient on different specific treatment compared to the other group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma treatment will not be assigned randomly, but will be administered at the discretion of the physicians according to standard medical practice. Each site should enrol 5 patients using the Symbicort® SMART® principle and 5 patients being prescribed a free combination GCS / LABA treatment.
Key inclusion criteria (6 listed)
- Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
- Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
- A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
- A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:
Key exclusion criteria (3 listed)
- Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
- Use of ß-blocking agents
- Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.
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
Use of rescue medication
Time frame: daily during 6 month
3 secondary outcomes
Quality of life
Time frame: 3 times during study
Efficacy variables
Time frame: during 6 month
Safety variables
Time frame: during 6 month
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 31 Mar 2011.
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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.
Kai Richter, MD study director
AstraZeneca
43 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 43 sites in Germany.
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 6 inclusion and 3 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 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in Germany. 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?
Use of rescue medication (time frame: daily during 6 month). 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 31 Mar 2011.