Symbicort vs Budesonide: Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00907 | 0.00694 | 0.0118 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0121 | 0.00964 | 0.0153 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00308 | -0.00687 | 0.000659 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.747 | 0.524 | 1.06 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.744 | 0.52 | 1.06 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Symbicort than on Budesonide | 325 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Symbicort | Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening). | 53 | 5,846 | OG000 | ClinicalTrials.gov |
| Group 2 | Budesonide | Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening). | 71 | 5,847 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation | ClinicalTrials.gov |
| Description | 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. | ClinicalTrials.gov |
| Time frame | Up to 26 weeks | ClinicalTrials.gov |
| Population | 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. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents | ClinicalTrials.gov |
| NCT number | NCT01444430 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Asthma | ClinicalTrials.gov |
| Interventions | Symbicort pMDI, budesonide pMDI | ClinicalTrials.gov |
| Lead sponsor | AstraZeneca | ClinicalTrials.gov |
| Results first posted | 2016-12-15 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01444430?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.