Trial · NCT01444430
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
NCT01444430, Phase 3, Completed, AstraZeneca; results first posted 2016-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents. Trials, record NCT01444430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01444430
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
- NCT number
- NCT01444430
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12,460 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Symbicort pMDI, budesonide pMDI
- First posted
- 2011-09-30
- Last updated
- 2016-12-15
- Other registries' IDs
- eudract:2011-002790-28
- Results first posted
- 2016-12-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) | Up to 27 weeks | Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated. |
| Primary | Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation | Up to 26 weeks | Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated. |
| Secondary | Percent of Days With no Asthma Symptoms | Daily up to 26 weeks | Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide. |
| Secondary | Percent of Days With Activity Limitation Due to Asthma | Daily up to 26 weeks | Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide. |
| Secondary | Mean Number of Puffs of Rescue Medication Per 24 Hours | Daily up to 26 weeks | Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide. |
| Secondary | Asthma Control Questionnaire (ACQ6) | baseline, day 28, day 84, day 182 | The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide. The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. |
| Secondary | Percent of Nights With Awakening(s) Due to Asthma | Daily up to 26 weeks | Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide. |
| Secondary | Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation | Up to 26 weeks | Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) | Up to 27 weeks | Full analysis set (FAS) population comprised of all patients randomized to study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation | Up to 26 weeks | The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient's period of exposure to study drug plus 7 days after the last date of study drug treatment. | Participants | NUMBER |
| SECONDARY | Percent of Days With no Asthma Symptoms | Daily up to 26 weeks | Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Days With Activity Limitation Due to Asthma | Daily up to 26 weeks | Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms. | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Number of Puffs of Rescue Medication Per 24 Hours | Daily up to 26 weeks | Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization. | Inhalations/day | LEAST_SQUARES_MEAN |
| SECONDARY | Asthma Control Questionnaire (ACQ6) | baseline, day 28, day 84, day 182 | Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score. | ACQ6 overall score change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Nights With Awakening(s) Due to Asthma | Daily up to 26 weeks | Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization. | Percentage of nights | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation | Up to 26 weeks | The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient's period of exposure to study drug plus 7 days after the last date of study drug treatment. | Participants | NUMBER |
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 Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) | Symbicort | 43 | Participants | ||
| Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) | Budesonide | 40 | Participants | ||
| Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation | Symbicort | 539 | Participants | ||
| Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation | Budesonide | 633 | Participants | ||
| Percent of Days With no Asthma Symptoms | Symbicort | 81.1 | Standard Error 0.4 | Percentage of days | |
| Percent of Days With no Asthma Symptoms | Budesonide | 76.8 | Standard Error 0.4 | Percentage of days | |
| Percent of Days With Activity Limitation Due to Asthma | Symbicort | 19.7 | Standard Error 0.4 | Percentage of days | |
| Percent of Days With Activity Limitation Due to Asthma | Budesonide | 19.1 | Standard Error 0.4 | Percentage of days | |
| Mean Number of Puffs of Rescue Medication Per 24 Hours | Symbicort | 0.8 | Standard Error 0.0 | Inhalations/day | |
| Mean Number of Puffs of Rescue Medication Per 24 Hours | Budesonide | 0.9 | Standard Error 0.0 | Inhalations/day |
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 | 5,846 | |
| Overall Study | STARTED | Budesonide | 5,847 | |
| Overall Study | COMPLETED | Symbicort | 5,785 | |
| Overall Study | COMPLETED | Budesonide | 5,766 | |
| Overall Study | NOT COMPLETED | Symbicort | 61 | |
| Overall Study | NOT COMPLETED | Budesonide | 81 |
Source ClinicalTrials.gov
Adverse events340
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 | Lymphadenopathy mediastinal | Blood and lymphatic system disorders | Symbicort | 1 | 5,846 | 1 |
| serious | Lymphadenopathy mediastinal | Blood and lymphatic system disorders | Budesonide | 0 | 5,847 | 0 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Symbicort | 0 | 5,846 | 0 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Budesonide | 1 | 5,847 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Symbicort | 1 | 5,846 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Budesonide | 1 | 5,847 | 1 |
| serious | Angina pectoris | Cardiac disorders | Symbicort | 3 | 5,846 | 3 |
| serious | Angina pectoris | Cardiac disorders | Budesonide | 1 | 5,847 | 1 |
| serious | Angina unstable | Cardiac disorders | Symbicort | 2 | 5,846 | 2 |
| serious | Angina unstable | Cardiac disorders | Budesonide | 1 | 5,847 | 1 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Symbicort | ||
| Total, all-cause mortality | Budesonide | ||
| Total, other adverse events | Symbicort | 0 | 5,846 |
| Total, other adverse events | Budesonide | 0 | 5,847 |
| Total, serious adverse events | Symbicort | 125 | 5,846 |
| Total, serious adverse events | Budesonide | 123 | 5,847 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27579635 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Symbicort vs Budesonide: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) | Trial comparisons |
| Symbicort vs Budesonide: Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation | Trial comparisons |
| Symbicort vs Budesonide: Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation | Trial comparisons |
| Symbicort vs Budesonide: serious adverse events | 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/NCT01444430
GET https://conductscience.org/api/trials/v1/NCT01444430/events?page=2