Bronchial AsthmaNCT00505388

A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice

An observational study of Bronchial Asthma, run by AstraZeneca at 695 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This patient follow-up programme was designed to describe the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of Symbicort as maintenance and reliever therapy in clinical therapies Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bronchial Asthma
How many people: 5,137 participants
Where: 695 sitesin 12 countries
Study dates: Jul 2007to Apr 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: The patients continued with their treatment (Symbicort SMART) after enrolment. Enrolment throug IVRS/IWRS, no randomisation. Primary care clinic.

Who may be able to join

Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme
signed and dated informed consent(ICF)
for patients under-age, signed and dated ICF form from both the patient and the patient's parent/legal guardian is required

Who cannot join

Involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)

Trial locations and contacts

695 sites in 12 countries.

Country

City, postcode or hospital

695 sites in 12 countries

Belgium220 sites

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About this study

Conditions: Bronchial Asthma
Keywords: asthma, bronchial, Symbicort
Medical subject headings: Asthma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Apr 2010

First posted23 Jul 2007 (estimated)
Study startJul 2007
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bronchial 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: Prospective
Enrolment: 5,137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00505388
Sponsor's protocol ID: D5890C00018
Other IDs: EuDract 2006-005677-22
Status last verified: Apr 2010
First submitted: 17 Jul 2007
Last updated: 18 Jan 2020
Results posted: No

Publications

Stallberg B, Naya I, Ekelund J, Eckerwall G. Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy. Int J Clin Pharmacol Ther. 2015 Jun;53(6):447-55. doi: 10.5414/CP202224.
PubMed 25907171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bronchial Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice
ClinicalTrials.gov ID: NCT00505388
Acronym / sponsor ID: D5890C00018
Conditions: Bronchial Asthma
Keywords: asthma, bronchial, Symbicort
Study type: Observational
Recruitment status: Completed
Enrolment: 5,137 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 23 Jul 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.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patients continued with their treatment (Symbicort SMART) after enrolment. Enrolment throug IVRS/IWRS, no randomisation. Primary care clinic.

Key inclusion criteria (3 listed)

Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme
signed and dated informed consent(ICF)
for patients under-age, signed and dated ICF form from both the patient and the patient's parent/legal guardian is required

Key exclusion criteria (1 listed)

Involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)

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

Not reported in the source record.

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 18 Jan 2020.
Derived from this study: PubMed 25907171Stallberg B, Naya I, Ekelund J, Eckerwall G. Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy. Int J Clin Pharmacol Ther. 2015 Jun;53(6):447-55. doi: 10.5414/CP202224.

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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.

Tomas Andersson, MD study director

AstraZeneca

Bjorn Stallberg, MD principal investigator

Trosa Vardcentral

695 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchial Asthma, run by AstraZeneca at 695 sites in 12 countries.

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 3 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 695 sites in Belgium, Germany, Netherlands, United Kingdom, Sweden and 7 more countries. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00505388, which also lists 1 linked publication.

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 18 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.