AsthmaPhase 4NCT00463866

Local Phase 4 Pan-European SMART Study

A Phase 4 study testing Budesonide/formoterol in people with Asthma, run by AstraZeneca at 817 sites in 14 countries.

Completed

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

Trial summary

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Budesonide/formoterol
How many people: 8,424 participants
Where: 817 sitesin 14 countries
Study dates: Mar 2007to Dec 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Patients at out-patient clinics
>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Who cannot join

Asthma exacerbation within the last 14 days prior to study start
subject aged >40 years with a smoking history of >10pack-years
subjects with chronic obstructive lung disease or other significant respiratory disease

Trial locations and contacts

817 sites in 14 countries.

Country

City, postcode or hospital

817 sites in 14 countries

France184 sites

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Agen
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Aix-en-Provence
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Ajaccio
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Amiens
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Germany130 sites

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United Kingdom95 sites

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Italy76 sites

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Spain61 sites

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Finland43 sites

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Netherlands27 sites

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Norway12 sites

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B�verbru
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Fevik
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Larvik
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Røa
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Ski
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Russia4 sites

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Moscow
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Saint Petersburg
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Iceland1 site

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About this study

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Conditions: Asthma
Being tested: Budesonide/formoterol
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.

Budesonide/formoterolDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Severe Asthma Exacerbations Per Participant.
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Measured: 6 months

Secondary outcomes (8)

Fraction of Participants With Severe Asthma Exacerbation
The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Measured: 6 months.
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant
Measured: 6 months.
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Measured: 6 months.
Mean Daily Number of Inhalations of As-needed Medication.
The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
Measured: 4 weeks
Percent of Participants With a Well Controlled Asthma Week.
The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.
Measured: 6 months.
Mean Overall Asthma Control Questionnaire (ACQ) Score
The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.
Measured: 6 months.
The Mean Total Daily Dose of Steroids From Symbicort.
The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
Measured: 4 weeks
Mean Cost Per Participant Per Country
Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.
Measured: 6 months

Timeline

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

Mar 2007Dec 2008

First posted20 Apr 2007 (estimated)
Study startMar 2007
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8,424 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00463866
Sponsor's protocol ID: D5890L00022
Other IDs: EUROSMART, EudraCTNo. 2006-006512-30
Status last verified: Mar 2010
First submitted: 19 Apr 2007
Last updated: 22 Mar 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17.
PubMed 21586508
Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.
PubMed 21435854
Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.
PubMed 20595145

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?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Local Phase 4 Pan-European SMART Study
ClinicalTrials.gov ID: NCT00463866
Acronym / sponsor ID: D5890L00022
Conditions: Asthma
Keywords: Asthma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,424 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2007
Study completion: Dec 2008 (actual)
First posted: 20 Apr 2007 (estimated)
Results: Posted 22 Mar 2010

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 evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients at out-patient clinics
>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Key exclusion criteria (3 listed)

Asthma exacerbation within the last 14 days prior to study start
subject aged >40 years with a smoking history of >10pack-years
subjects with chronic obstructive lung disease or other significant respiratory disease

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
Budesonide/formoterol	Drug	–

Primary outcome

Number of Severe Asthma Exacerbations Per Participant.
Time frame: 6 months
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

8 secondary outcomes

Fraction of Participants With Severe Asthma Exacerbation
Time frame: 6 months.
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
Time frame: 6 months.
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
Time frame: 6 months.
Mean Daily Number of Inhalations of As-needed Medication.
Time frame: 4 weeks
Percent of Participants With a Well Controlled Asthma Week.
Time frame: 6 months.
Mean Overall Asthma Control Questionnaire (ACQ) Score
Time frame: 6 months.
The Mean Total Daily Dose of Steroids From Symbicort.
Time frame: 4 weeks
Mean Cost Per Participant Per Country
Time frame: 6 months

Results and safety

Results posted to the registry on 22 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort® SMART®) 1*2	4,008	3,699
Symbicort® SMART®) 2*2	4,045	3,705

Primary outcome: Number of Severe Asthma Exacerbations Per Participant.

Time frame: 6 months. Mean (Full Range). Unit: Severe exacerbations per participant

Measure	Symbicort® SMART®) 1*2 n = 4008	Symbicort® SMART®) 2*2 n = 4045
Value	0.097 (0)	0.080 (0)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort® SMART®) 1*2	77 of 4,008 (1.9%)	0 of 4,008 (0%)	Not reported
Symbicort® SMART®) 2*2	88 of 4,045 (2.2%)	0 of 4,045 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21586508Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17.
Derived from this study: PubMed 21435854Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.
Derived from this study: PubMed 20595145Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.

Related trials for Asthma

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma
Active, not recruiting
Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Asthma in Children, Chronic Diseases in Children
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
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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.

Michel Aubier, Prof principal investigator

FRANCE

Juliette Ostinelli, MD study chair

AstraZeneca, MC France

817 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Budesonide/formoterol in people with Asthma, run by AstraZeneca at 817 sites in 14 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 2 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 22 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 817 sites in France, Germany, Belgium, United Kingdom, Italy and 9 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Severe Asthma Exacerbations Per Participant. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00463866, which also lists 3 linked publications.

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 22 Mar 2010; AzTrials last refreshed its copy on 26 Oct 2026.