Trial · NCT00463866
Local Phase 4 Pan-European SMART Study
NCT00463866, Phase 4, Completed, AstraZeneca; results first posted 2010-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Local Phase 4 Pan-European SMART Study. Trials, record NCT00463866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00463866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Local Phase 4 Pan-European SMART Study
- NCT number
- NCT00463866
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 8,424 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Budesonide/formoterol
- First posted
- 2007-04-20
- Last updated
- 2010-03-22
- Other registries' IDs
- eudract:2006-006512-30
- Results first posted
- 2010-03-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Severe Asthma Exacerbations Per Participant. | 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. |
| Secondary | Fraction of Participants With Severe Asthma Exacerbation | 6 months. | 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. |
| Secondary | Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. | 6 months. | 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 |
| Secondary | Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation | 6 months. | 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. |
| Secondary | Mean Daily Number of Inhalations of As-needed Medication. | 4 weeks | The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment. |
| Secondary | Percent of Participants With a Well Controlled Asthma Week. | 6 months. | 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. |
| Secondary | Mean Overall Asthma Control Questionnaire (ACQ) Score | 6 months. | 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. |
| Secondary | The Mean Total Daily Dose of Steroids From Symbicort. | 4 weeks | The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose. |
| Secondary | Mean Cost Per Participant Per Country | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Severe Asthma Exacerbations Per Participant. | 6 months | Severe exacerbations per participant | MEAN | |
| SECONDARY | Fraction of Participants With Severe Asthma Exacerbation | 6 months. | Fraction of participants with event | MEAN | |
| SECONDARY | Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. | 6 months. | Number of events per participant | MEAN | |
| SECONDARY | Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation | 6 months. | Days per participant | MEAN | |
| SECONDARY | Mean Daily Number of Inhalations of As-needed Medication. | 4 weeks | Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2\*2 Reporting Group | Inhalations per day per participant | MEAN |
| SECONDARY | Percent of Participants With a Well Controlled Asthma Week. | 6 months. | Data for this measure recorded by 3714 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2\*2 Reporting Group. | Percentage of participants | MEAN |
| SECONDARY | Mean Overall Asthma Control Questionnaire (ACQ) Score | 6 months. | Data for this measure recorded by 3709 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2\*2 Reporting Group. | Scores in a scale | MEAN |
| SECONDARY | The Mean Total Daily Dose of Steroids From Symbicort. | 4 weeks | : Data for this measure recorded by 3874 participants in the Symbicort SMART 1\*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2\*2 Reporting Group. | μg budesonide per day | MEAN |
| SECONDARY | Mean Cost Per Participant Per Country | 6 months | Euro | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Severe Asthma Exacerbations Per Participant. | Symbicort® SMART®) 1*2 | 0.097 | Full Range 0 | Severe exacerbations per participant | |
| Number of Severe Asthma Exacerbations Per Participant. | Symbicort® SMART®) 2*2 | 0.080 | Full Range 0 | Severe exacerbations per participant | |
| Fraction of Participants With Severe Asthma Exacerbation | Symbicort® SMART®) 1*2 | 0.09686 | 95% Confidence Interval 0.08528 | Fraction of participants with event | |
| Fraction of Participants With Severe Asthma Exacerbation | Symbicort® SMART®) 2*2 | 0.07955 | 95% Confidence Interval 0.06927 | Fraction of participants with event | |
| Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. | Symbicort® SMART®) 1*2 | 0.0120 | Full Range 0 | Number of events per participant | |
| Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. | Symbicort® SMART®) 2*2 | 0.0091 | Full Range 0 | Number of events per participant | |
| Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation | Symbicort® SMART®) 1*2 | 9.6 | Standard Deviation 8.1 | Days per participant | |
| Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation | Symbicort® SMART®) 2*2 | 9.1 | Standard Deviation 5.5 | Days per participant | |
| Mean Daily Number of Inhalations of As-needed Medication. | Symbicort® SMART®) 1*2 | 0.897 | Full Range 0 | Inhalations per day per participant | |
| Mean Daily Number of Inhalations of As-needed Medication. | Symbicort® SMART®) 2*2 | 0.625 | Full Range 0 | Inhalations per day per participant |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Symbicort® SMART®) 1*2 | 4,008 | |
| Overall Study | STARTED | Symbicort® SMART®) 2*2 | 4,045 | |
| Overall Study | COMPLETED | Symbicort® SMART®) 1*2 | 3,699 | |
| Overall Study | COMPLETED | Symbicort® SMART®) 2*2 | 3,705 | |
| Overall Study | NOT COMPLETED | Symbicort® SMART®) 1*2 | 309 | |
| Overall Study | NOT COMPLETED | Symbicort® SMART®) 2*2 | 340 |
Source ClinicalTrials.gov
Adverse events230
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Symbicort® SMART®) 1*2 | 1 | 4,008 | |
| serious | Anaemia | Blood and lymphatic system disorders | Symbicort® SMART®) 2*2 | 1 | 4,045 | |
| serious | Angina Pectoris | Cardiac disorders | Symbicort® SMART®) 1*2 | 1 | 4,008 | |
| serious | Angina Pectoris | Cardiac disorders | Symbicort® SMART®) 2*2 | 1 | 4,045 | |
| serious | Atrial Fibrillation | Cardiac disorders | Symbicort® SMART®) 1*2 | 2 | 4,008 | |
| serious | Atrial Fibrillation | Cardiac disorders | Symbicort® SMART®) 2*2 | 1 | 4,045 | |
| serious | Atrioventricular Block | Cardiac disorders | Symbicort® SMART®) 1*2 | 1 | 4,008 | |
| serious | Atrioventricular Block | Cardiac disorders | Symbicort® SMART®) 2*2 | 0 | 4,045 | |
| serious | Coronary Artery Disease | Cardiac disorders | Symbicort® SMART®) 1*2 | 1 | 4,008 | |
| serious | Coronary Artery Disease | Cardiac disorders | Symbicort® SMART®) 2*2 | 0 | 4,045 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Symbicort® SMART®) 1*2 | ||
| Total, all-cause mortality | Symbicort® SMART®) 2*2 | ||
| Total, other adverse events | Symbicort® SMART®) 1*2 | 0 | 4,008 |
| Total, other adverse events | Symbicort® SMART®) 2*2 | 0 | 4,045 |
| Total, serious adverse events | Symbicort® SMART®) 1*2 | 77 | 4,008 |
| Total, serious adverse events | Symbicort® SMART®) 2*2 | 88 | 4,045 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Symbicort® SMART®) 1*2 vs Symbicort® SMART®) 2*2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00463866
GET https://conductscience.org/api/trials/v1/NCT00463866/events?page=2