Moderate/Severe AsthmaNCT00785733
NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART
An observational study of Moderate/Severe Asthma, run by AstraZeneca at 44 sites in Romania.
Trial summary
The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate/Severe Asthma
- How many people
- 1,182 participants
- Where
- 44 sitesRomania
- Study dates
- Nov 2008to Oct 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: The programme will include patients with moderate and severe asthma stabilized on Symbicort SMART from community sample
Who may be able to join
- patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program
- All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.
Who cannot join
- All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study.
- As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Romania44 sites
Research Site
Alba Iulia
Research Site
Alexandria
Research Site
Arad
Research Site
Bacau
Research Site
Baia Mare
Research Site
Botoșani
Research Site
Brăila
Research Site
Brasov
Research Site
Breaza
Research Site
Bucharest
Research Site
Buftea
Research Site
Calarasi
Research Site
Câmpina
Research Site
Campulung Muscel
Research Site
Cluj-Napoca
Research Site
Constanța
Research Site
Craiova
Research Site
Deva
Research Site
Drobeta-Turnu Severin
Research Site
Giurgiu
Research Site
Hunedoara
Research Site
Iași
Research Site
Leordeni
Research Site
Miercurea-Ciuc
Research Site
Mizil
Research Site
Oradea
Research Site
Palazu Mare
Research Site
Piatra Neamţ
Research Site
Piteşti
Research Site
Ploieşti
Research Site
Reşiţa
Research Site
Rm. Valcea
Research Site
Scorniceşti
Research Site
Sf. Gheorghe
Research Site
Sibiu
Research Site
Slobozia
Research Site
Suceava
Research Site
Targoviste
Research Site
Târgu Mureş
Research Site
Tg. Jiu
Research Site
Timișoara
Research Site
Tulcea
Research Site
Vaslui
Research Site
Zalău
About this study
Official title: SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma
The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period
- Conditions
- Moderate/Severe Asthma
- Keywords
- asthma
- Medical subject headings
- Lymphoma, Follicular, 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 | Moderate and severe asthma patients stabilized on Symbicort SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire ACQ
Measured: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate/Severe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,182 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cristina Pentiuc, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785733
- Sponsor's protocol ID
- NIS-RRO-SYM-2008/1
- Status last verified
- Nov 2010
- First submitted
- 4 Nov 2008
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma
- ClinicalTrials.gov ID
- NCT00785733
- Acronym / sponsor ID
- NIS-RRO-SYM-2008/1
- Conditions
- Moderate/Severe Asthma
- Keywords
- asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,182 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 5 Nov 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.
The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Moderate and severe asthma patients stabilized on Symbicort SMART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The programme will include patients with moderate and severe asthma stabilized on Symbicort SMART from community sample
Key inclusion criteria (2 listed)
- patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program
- All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.
Key exclusion criteria (2 listed)
- All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study.
- As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
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
Asthma Control Questionnaire ACQ
Time frame: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24)
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 2 Dec 2010.
Related trials for Moderate/Severe Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingPhase 2
A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma
Asthma
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
Not yet recruitingPhase 1
A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study of Multiple Ascending Doses of EB070 Injection in Adults With Moderate-to-Severe Asthma
Asthma
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.
Cristina Pentiuc study chair
AstraZeneca
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate/Severe Asthma, run by AstraZeneca at 44 sites in Romania.
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 2 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 44 sites in Romania. 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?
Asthma Control Questionnaire ACQ (time frame: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24)). 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 2 Dec 2010.