Trial · NCT00839800
Study to Investigate the Efficacy of Symbicort® SMART.
NCT00839800, Phase 3, Completed, AstraZeneca; results first posted 2012-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate the Efficacy of Symbicort® SMART. Trials, record NCT00839800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00839800
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate the Efficacy of Symbicort® SMART.
- NCT number
- NCT00839800
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,091 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Symbicort Turbuhaler, Terbutaline Turbuhaler
- First posted
- 2009-02-10
- Last updated
- 2012-11-30
- Results first posted
- 2012-11-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | week 52 | Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment. |
| Secondary | Number of Asthma Exacerbations | up to 52 weeks | Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here. |
| Secondary | Morning Peak Expiratory Flow (PEF) | 52-week treatment period | The mean value from a 52-week treatment period. |
| Secondary | Evening PEF | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period | The mean value from a 52-week treatment period. |
| Secondary | Forced Expiratory Volume in One Second (FEV1) | 4, 12, 24, 36 and 52 weeks after randomization | The mean value for Weeks 4, 12, 24, 36 and 52 was analysed. |
| Secondary | Use of As-needed Medication | 52-week treatment period | The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time). |
| Secondary | Asthma Symptom Score | 52-week treatment period | The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst). |
| Secondary | Nights With Awakening(s) Due to Asthma Symptoms | 52-week treatment period | The mean value from the treatment period was presented here. |
| Secondary | The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | up to 52 weeks | Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here. |
| Secondary | Symptom-free Days (no Symptoms and no Awakenings) | 52-week treatment period | A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | week 52 | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | percentage of participants | NUMBER |
| SECONDARY | Number of Asthma Exacerbations | up to 52 weeks | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Asthma exacerbations | NUMBER |
| SECONDARY | Morning Peak Expiratory Flow (PEF) | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Liter/minute (L/min) | MEAN |
| SECONDARY | Evening PEF | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | L/min | MEAN |
| SECONDARY | Forced Expiratory Volume in One Second (FEV1) | 4, 12, 24, 36 and 52 weeks after randomization | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Liter (L) | GEOMETRIC_MEAN |
| SECONDARY | Use of As-needed Medication | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | inhalations/day | MEAN |
| SECONDARY | Asthma Symptom Score | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | units on a scale | MEAN |
| SECONDARY | Nights With Awakening(s) Due to Asthma Symptoms | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Nights With Awakening(s) | MEAN |
| SECONDARY | The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | up to 52 weeks | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | percentage of participants | NUMBER |
| SECONDARY | Symptom-free Days (no Symptoms and no Awakenings) | 52-week treatment period | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | symptom-free days | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | Symbicort SMART | 16 | percentage of participants | ||
| The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | Symbicort+Terbutaline As Needed | 22 | percentage of participants | ||
| Number of Asthma Exacerbations | Symbicort SMART | 259 | Asthma exacerbations | ||
| Number of Asthma Exacerbations | Symbicort+Terbutaline As Needed | 363 | Asthma exacerbations | ||
| Morning Peak Expiratory Flow (PEF) | Symbicort SMART | 331.8 | Standard Deviation 102.2 | Liter/minute (L/min) | |
| Morning Peak Expiratory Flow (PEF) | Symbicort+Terbutaline As Needed | 324.7 | Standard Deviation 101.9 | Liter/minute (L/min) | |
| Evening PEF | Symbicort SMART | 334.2 | Standard Deviation 102.6 | L/min | |
| Evening PEF | Symbicort+Terbutaline As Needed | 327.8 | Standard Deviation 103.1 | L/min | |
| Forced Expiratory Volume in One Second (FEV1) | Symbicort SMART | 2.258 | Standard Deviation 0.76 | Liter (L) | |
| Forced Expiratory Volume in One Second (FEV1) | Symbicort+Terbutaline As Needed | 2.222 | Standard Deviation 0.77 | Liter (L) |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 | 1,049 | |
| Overall Study | STARTED | Symbicort+Terbutaline As Needed | 1,042 | |
| Overall Study | COMPLETED | Symbicort SMART | 956 | |
| Overall Study | COMPLETED | Symbicort+Terbutaline As Needed | 932 | |
| Overall Study | NOT COMPLETED | Symbicort SMART | 93 | |
| Overall Study | NOT COMPLETED | Symbicort+Terbutaline As Needed | 110 |
Source ClinicalTrials.gov
Adverse events156
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 |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Symbicort SMART | 137 | 1,049 | |
| other | Nasopharyngitis | Infections and infestations | Symbicort+Terbutaline As Needed | 133 | 1,042 | |
| other | Bronchitis | Infections and infestations | Symbicort SMART | 69 | 1,049 | |
| other | Bronchitis | Infections and infestations | Symbicort+Terbutaline As Needed | 77 | 1,042 | |
| other | Viral Upper Respiratory Tract Infection | Infections and infestations | Symbicort SMART | 60 | 1,049 | |
| other | Viral Upper Respiratory Tract Infection | Infections and infestations | Symbicort+Terbutaline As Needed | 72 | 1,042 | |
| other | Pharyngitis | Infections and infestations | Symbicort SMART | 49 | 1,049 | |
| other | Pharyngitis | Infections and infestations | Symbicort+Terbutaline As Needed | 58 | 1,042 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Symbicort SMART | 0 | 1,049 | |
| serious | Acute Myocardial Infarction | Cardiac disorders | Symbicort+Terbutaline As Needed | 1 | 1,042 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Symbicort SMART | ||
| Total, all-cause mortality | Symbicort+Terbutaline As Needed | ||
| Total, other adverse events | Symbicort SMART | 279 | 1,049 |
| Total, other adverse events | Symbicort+Terbutaline As Needed | 293 | 1,042 |
| Total, serious adverse events | Symbicort SMART | 41 | 1,049 |
| Total, serious adverse events | Symbicort+Terbutaline As Needed | 74 | 1,042 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32718193 | DERIVED |
Source PubMed
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 vs Symbicort+Terbutaline As Needed: 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/NCT00839800
GET https://conductscience.org/api/trials/v1/NCT00839800/results?page=2