This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg (NCT02091986), a randomized phase 3 study. The primary outcome is Change From Baseline to Week 12 in 1h Post-dose FEV1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02091986 |
| Phase | Phase 3 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 882 |
| Arms in the primary outcome | 3 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Children ages 6 to <12 years with asthma were eligible for this Phase 3 study. The primary endpoint population consisted of randomized patients who received at least one dose of study medication and contributed data for at least one efficacy endpoint. Patients were analyzed according to their randomized treatment.
Intervention
One group received Symbicort pMDI 80/4.5 µg, two actuations twice daily. Another received Symbicort pMDI 80/2.25 µg, also two actuations twice daily. Symbicort is described in the arm information as budesonide/formoterol.
Comparator
The comparator group received budesonide pMDI 80 µg, two actuations twice daily. The study was randomized, double-blind, and parallel-group; the registry describes masking as quadruple.
Primary question
The primary question concerned change from baseline to Week 12 in 1-hour post-dose FEV1, measured in liters. The registry reports adjusted least-squares means and 95% confidence intervals for the treatment groups, along with mixed-model p values for comparisons. The key interpretive issue is how these group estimates and model-based comparisons describe the observed lung-function endpoint, and how much uncertainty remains around them.
The registry lists three treatment groups and an enrollment of 882. The primary endpoint description defines the measurement as the Week 12 1-hour post-dose value minus the pre-dose measurement at randomization, for patients who remained in the study whether or not study medication had been discontinued. This definition matters: it identifies a change over time, not simply a Week 12 measurement, and the endpoint population is specified separately from the enrollment figure.
The registry record does not report a formal hypothesis statement or a stated minimum clinically important difference. The numerical results therefore describe group changes and reported statistical comparisons, but do not by themselves establish what magnitude of change would be important to patients or clinicians.
3. Trial Design
This was a Phase 3, randomized, quadruple-masked, parallel-group, multicenter study of children with asthma. The title and study description identify a 12-week treatment period. The study compared Symbicort pMDI 80/4.5 µg and Symbicort pMDI 80/2.25 µg, each given as two actuations twice daily, with budesonide pMDI 80 µg, also given as two actuations twice daily. The registry lists AstraZeneca as sponsor and reports the study as completed.
The registry reports enrollment of 882. That is the enrollment figure, not the number contributing primary endpoint data in each treatment group. For the primary endpoint, the posted group estimates are based on 90 patients for Symbicort 80/4.5 µg, 93 for Symbicort 80/2.25 µg, and 90 for budesonide. The specified primary population required randomization, at least one dose of study medication, and contribution of data for at least one efficacy endpoint. Analysis followed randomized assignment.
Randomization and masking are relevant design protections against systematic differences in treatment assignment and outcome assessment. General statistical context: random allocation can support fairer comparisons of groups, while masking can reduce the influence of treatment knowledge on behavior, co-interventions, or measurement. Those design features do not remove uncertainty from sampling variation, missing observations, or limitations in the reporting.
The registry record does not report details of the randomization sequence, allocation concealment, masking procedures, site count, adherence, or the statistical analysis plan. The record also does not report a sample-size justification for this trial. Although planning illustrations are available for selected secondary comparisons, those are recalculations from observed effects and are not evidence of the original design rationale or of the trial’s achieved power.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: The enrollment number in the protocol section denotes the number of patients screened into the trial. Out of these 882 patients screened, 279 patients were randomized into the trial. This explains the discrepancy in patient number.
Overall Study
| Stage | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/2.25 ug | Budesonide pMDI 80 ug |
|---|---|---|---|
| STARTED | 92 | 95 | 92 |
| COMPLETED | 85 | 84 | 84 |
| NOT COMPLETED | 7 | 11 | 8 |
Reasons for not completing this period:
| Reason | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/2.25 ug | Budesonide pMDI 80 ug |
|---|---|---|---|
| 7 rand in error 1 patient decision | 2 | 3 | 3 |
| Lost to Follow-up | 1 | 0 | 0 |
| Withdrawal by Subject | 4 | 8 | 3 |
| Adverse Event | 0 | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: All patients randomized who: * received at least one dose of study medication; * the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All patients randomized, defined as having a randomization code recorded on the demography case report form (CRF)
| Characteristic | Unit | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/2.25 ug | Budesonide pMDI 80 ug | Total |
|---|---|---|---|---|---|
| Participants analysed | 92 | 95 | 92 | 279 | |
| Age, Continuous | years | 9 (SD 1.6) | 9 (SD 1.6) | 9 (SD 1.4) | 9 (SD 1.5) |
| Sex: Female, Male: Female | Participants | 42 | 34 | 37 | 113 |
| Sex: Female, Male: Male | Participants | 50 | 61 | 55 | 166 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 38 | 36 | 32 | 106 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 54 | 59 | 60 | 173 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 3 | 3 | 8 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 2 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 24 | 26 | 26 | 76 |
| Race (NIH/OMB): White | Participants | 61 | 60 | 53 | 174 |
| Race (NIH/OMB): More than one race | Participants | 4 | 4 | 7 | 15 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 1 | 3 |
| Weight | kg | 38 (SD 12.9) | 38 (SD 12.9) | 40 (SD 13.6) | 39 (SD 13.1) |
| Height | cm | 139 (SD 11.1) | 138 (SD 10.9) | 141 (SD 10.5) | 139 (SD 10.8) |
| Duration of asthma | years | 5.8 (SD 3.0) | 5.9 (SD 3.2) | 6.2 (SD 3.1) | 5.9 (SD 3.1) |
| FEV1 at randomisation | Liters | 1.58 (SD 0.42) | 1.57 (SD 0.33) | 1.62 (SD 0.36) | 1.59 (SD 0.37) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline to Week 12 in 1h Post-dose FEV1, measured over Week 0 (baseline), Week 12.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Liters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline to Week 12 in 1-hour post-dose FEV1, in liters. FEV1 is forced expiratory volume in one second: the volume of air exhaled during the first second of a forced breathing maneuver. The registry defines the endpoint as the 1-hour post-dose measurement at Week 12 minus the pre-dose measurement taken at randomization. A positive change therefore represents a higher measured volume at the later assessment than at baseline; this is a description of the measurement’s direction, not a judgment about clinical importance.
The registry reports least-squares means and 95% confidence intervals for each group. Least-squares means are model-based estimates rather than simple arithmetic averages, although the registry record does not report the model specification used to produce them. The posted values are 0.28 liters for Symbicort 80/4.5 µg, 0.24 liters for Symbicort 80/2.25 µg, and 0.17 liters for budesonide. Their respective 95% confidence intervals are 0.22 to 0.34, 0.18 to 0.31, and 0.1 to 0.23.
FEV1 is used as a lung-function measure because it quantifies airflow during a standardized forced expiration. General statistical context: measuring change can account for baseline values in the outcome definition, but interpretation still depends on the analysis model, the amount and pattern of missing data, and the clinical meaning of the observed scale. A threshold for clinically important change is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry’s primary endpoint estimates are positive in all three groups: 0.28 liters for Symbicort 80/4.5 µg, 0.24 liters for Symbicort 80/2.25 µg, and 0.17 liters for budesonide. Their 95% confidence intervals are 0.22 to 0.34, 0.18 to 0.31, and 0.1 to 0.23, respectively. These are least-squares mean changes from baseline, not direct estimates of the difference between treatments. The registry does not provide treatment-difference estimates or confidence intervals alongside these arm-level values.
The reported mixed-model analyses list p = 0.006 for one Symbicort 80/4.5 µg versus budesonide comparison and p = 0.063 for Symbicort 80/2.25 µg versus budesonide. A further registry entry gives p = 0.373 for the same 80/4.5 µg versus budesonide pair. Because two entries name that same pair but report different p values, their relationship is not clear from the registry record. The model estimates, confidence intervals, and other details needed to resolve that ambiguity are not reported in the registry record.
A p value describes how compatible the observed data are with a specified statistical model and null hypothesis; it does not measure the size or clinical importance of a difference. General statistical context: a p value below a conventional threshold is not a substitute for an estimated treatment difference and its uncertainty. The registry record does not state the threshold used for its primary comparison, whether the analyses were adjusted for multiple testing, or which of the two entries for the 80/4.5 µg comparison should be treated as definitive.
The group confidence intervals describe uncertainty around each group’s estimated mean change. They should not be read as confidence intervals for between-group contrasts. Overlap or non-overlap of separate group intervals is not a direct replacement for a model-based comparison, because the uncertainty of a contrast depends on the joint model and covariance structure. Those comparison details are not reported in the registry record.
Accordingly, the posted primary results support a cautious reading: the group estimates show positive mean changes, and the registry lists mixed-model p values for treatment comparisons, but the record does not provide enough information to quantify the primary between-group effects or fully reconcile the duplicated comparison entry. No conclusion about clinical importance follows from these statistical summaries alone.
9. Statistical Methods Explained
The primary outcome is continuous and is reported as a least-squares mean change in liters. The registry gives group estimates with 95% confidence intervals and reports mixed-model analyses for pairwise treatment comparisons. The record does not specify the model formula, covariates, covariance structure, handling of repeated measurements, or the estimation method. Consequently, the registry’s p values can be described as mixed-model results, but the exact model assumptions and the route from the underlying observations to those results cannot be independently assessed from the record.
What a confidence interval conveys
General statistical explanation: a confidence interval expresses the uncertainty of an estimate under a specified sampling and modeling procedure. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. For the primary outcome, the registry reports 95% confidence intervals around the group least-squares means. These intervals concern each group’s estimated change, not the difference between two groups. A treatment contrast needs its own estimate and interval to show both the direction and precision of the comparison.
The reported analyses give p values but no treatment-difference estimate or confidence interval. A p value alone does not reveal whether a contrast is small or large, nor does it show the range of effect sizes reasonably compatible with the data. General statistical context: confidence intervals are especially useful alongside p values because they make the uncertainty and scale of an estimate more visible. Here, the registry record does not report those contrast intervals.
Why model details matter
Mixed models can account for the structure of repeated or otherwise related observations, depending on how they are specified. General statistical explanation: the model’s fixed effects, random effects, covariance assumptions, and handling of incomplete measurements influence the estimates and their standard errors. The registry identifies a mixed-model method but does not report these specifications. It also does not report whether baseline was included as a covariate, how visits were represented, or what assumptions were made about missing outcomes. These gaps limit interpretation and reproducibility.
The analysis population is defined as randomized patients who received at least one dose and contributed at least one efficacy endpoint, with patients analyzed according to randomized treatment. This is a modified subset of all randomized patients as described by the registry, rather than a statement that every randomized patient contributed the primary measurement. The record does not report how many patients lacked primary endpoint data, why data were missing, or how missing values were handled in the mixed model.
Unadjusted recalculations and planning illustrations
For selected secondary outcomes, posted recalculations use group summary statistics to estimate unadjusted mean differences and confidence intervals. These are straightforward, unadjusted comparisons and should not be mistaken for the sponsor’s mixed-model analysis. They do not adjust for baseline factors, repeated measurements, or multiple comparisons. The registry’s sponsor-reported analyses take precedence when a discrepancy is present; the discrepancy flag is false for this record.
Planning illustrations use the observed effect as a starting point and show participants per arm for 80% or 90% power under the stated assumptions: two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. Some illustrations consider planning for 100%, 75%, or 50% of the observed effect. General statistical explanation: such illustrations are sensitive to the assumed effect size and variability, and smaller assumed effects require larger planning samples to reach the same target power. They are not estimates of the power achieved by this trial, and they do not establish the trial’s original sample-size rationale. That rationale is not reported in the registry record.
Multiplicity and interpretation
The record includes multiple outcomes and more than one reported analysis. General statistical explanation: testing multiple hypotheses increases the chance that at least one result appears statistically notable by chance if no adjustment or prespecified testing strategy is used. The registry record does not report a multiplicity procedure, a hierarchical testing strategy, or which analyses were primary, secondary, or otherwise prespecified beyond identifying the primary endpoint. Therefore, the listed p values should be interpreted as reported, without assuming adjustment or a particular family-wise error strategy.
The registry lists 14 outcome measures and 30 analyses. The primary endpoint is one part of this broader set. General statistical explanation: a large collection of estimates can be useful for understanding outcome patterns, but it requires attention to the analysis plan, multiplicity, precision, and completeness of reporting. Those details are needed to distinguish confirmatory evidence from exploratory findings.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Mixed Models Analysis | not reported | 0.006 | |
| Mixed Models Analysis | not reported | 0.063 | |
| Mixed Models Analysis | not reported | 0.373 |
The registry identifies mixed models as the method for its reported primary comparisons. It lists p = 0.006 and p = 0.373 for the Symbicort 80/4.5 µg versus budesonide pair, and p = 0.063 for Symbicort 80/2.25 µg versus budesonide. The two entries for the 80/4.5 µg comparison make the reported result difficult to interpret: the registry record does not explain whether they reflect separate models, analyses, or a reporting issue. It also does not provide a model-based treatment difference or confidence interval for these comparisons.
The arm-level least-squares means and intervals describe changes within each group; they cannot resolve the inconsistency between the two p values for the same listed pair. Nor can unadjusted calculations from secondary summary statistics substitute for the primary mixed-model comparison. The discrepancy flag is false, so no documented discrepancy calls for an alternative recalculation to take precedence. The sponsor’s stated method and reported analyses remain the relevant results, while the duplicated entry and missing contrast estimates limit how completely they can be interpreted.
The record does not report the statistical analysis plan, detailed model specification, or an explanation of the p-value entries. It is therefore not possible to determine from the registry record which 80/4.5 µg comparison result was intended as the principal analysis, or how the reported analyses relate to any prespecified multiplicity strategy. The p values should be presented as registry-reported findings, not silently selected or reconciled.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 30 analyses, including the primary endpoint and multiple secondary outcomes. It does not report whether statistical testing was adjusted for multiplicity, whether a hierarchy or gatekeeping sequence was prespecified, or which comparisons were intended to support confirmatory conclusions. Without that information, the listed p values should be treated as reported results rather than as evidence that a particular error-rate strategy was followed.
General statistical explanation: when many hypotheses are tested, the chance of at least one apparently unusual result can increase. Prespecified control procedures can address this, but they generally affect how p values or confidence intervals are interpreted. The registry record does not report such procedures, so no adjusted interpretation can be reconstructed. The duplicate p-value entries for the Symbicort 80/4.5 µg versus budesonide comparison add a separate reporting ambiguity that multiplicity information alone would not resolve.
The primary endpoint population includes randomized patients who received at least one dose and contributed data to at least one efficacy endpoint, analyzed according to randomized assignment. The registry does not report the number of randomized patients excluded from that population, the number missing the Week 12 measurement, or the reasons for missingness. It also does not report the method used to handle missing data, assumptions about why values were missing, sensitivity analyses, or imputation procedures.
General statistical explanation: missing-data methods depend on assumptions about the relationship between missingness and observed or unobserved outcomes. Different assumptions can lead to different estimates, so transparent reporting and sensitivity analyses help readers judge robustness. A mixed model may use incomplete repeated measurements under particular assumptions, but the registry’s brief method label is insufficient to determine whether or how that was done.
The registry record does not report whether interim analyses occurred or whether any stopping rules were used. It also does not report the protocol’s sample-size justification. Planning illustrations based on observed secondary effects are not evidence of those design choices and should not be interpreted as observed power.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Symbicort pMDI 80/4.5 ug | 0 | 90 | 0.0% |
| Symbicort pMDI 80/2.25 ug | 0 | 93 | 0.0% |
| Budesonide pMDI 80 ug | 2 | 90 | 2.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Symbicort pMDI 80/4.5 ug | 42 of 90 |
| Symbicort pMDI 80/2.25 ug | 41 of 93 |
| Budesonide pMDI 80 ug | 40 of 90 |
Most frequent serious adverse event terms
| Event term | Organ system | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/2.25 ug | Budesonide pMDI 80 ug |
|---|---|---|---|---|
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 90 | 0 of 93 | 1 of 90 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 90 | 0 of 93 | 1 of 90 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Symbicort pMDI 80/4.5 ug | Symbicort pMDI 80/2.25 ug | Budesonide pMDI 80 ug |
|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | 7 of 90 | 11 of 93 | 10 of 90 |
| Upper respiratory tract infection | Infections and infestations | 9 of 90 | 12 of 93 | 4 of 90 |
| Pyrexia | General disorders | 4 of 90 | 4 of 93 | 4 of 90 |
| Nasopharyngitis | Infections and infestations | 4 of 90 | 2 of 93 | 5 of 90 |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 3 of 90 | 3 of 93 | 4 of 90 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 90 | 4 of 93 | 4 of 90 |
| Pharyngitis | Infections and infestations | 5 of 90 | 3 of 93 | 1 of 90 |
| Headache | Nervous system disorders | 4 of 90 | 4 of 93 | 0 of 90 |
| Rhinitis | Infections and infestations | 3 of 90 | 2 of 93 | 2 of 90 |
| Vomiting | Gastrointestinal disorders | 2 of 90 | 3 of 93 | 0 of 90 |
Serious events with the highest arm-level rate: acute lymphocytic leukaemia (1.1%), asthma (1.1%).
For serious adverse events, the registry reports zero affected patients in each Symbicort group and 2 in the budesonide group. The corresponding groups at risk are 90, 93, and 90. The record separately lists acute lymphocytic leukaemia and asthma as serious adverse event terms, each at 1.1%; it does not clearly connect those listed terms to specific treatment groups in the displayed information. Death counts are not reported in the registry record.
For other, non-serious adverse events, the registry reports 42 affected patients in the Symbicort 80/4.5 µg group, 41 in the Symbicort 80/2.25 µg group, and 40 in the budesonide group. The groups at risk are 90, 93, and 90, respectively. These are counts, not estimates of comparative risk adjusted for follow-up or other factors. The registry record does not provide event-level detail for these other adverse events in the registry record described.
General statistical context: adverse-event counts are descriptive and should be interpreted with attention to exposure duration, event definitions, completeness of reporting, and the number of patients observed. This study lasted 12 weeks, and the record does not report exposure-adjusted analyses or a detailed safety analysis plan. Small counts of serious events are particularly imprecise; the figures alone do not establish a causal relationship or support a comparative safety conclusion.
13. What the Result Does, and Does Not, Mean
The posted primary results describe positive mean changes in 1-hour post-dose FEV1 in each treatment group over the specified interval. The registry also reports mixed-model p values for treatment comparisons. These are different kinds of information: group estimates describe within-group change, while a valid comparative conclusion depends on the model-based contrast between groups and its uncertainty.
The record does not provide the primary treatment-difference estimates or confidence intervals, and two p-value entries refer to the same Symbicort 80/4.5 µg versus budesonide comparison. Those limitations prevent a complete account of the size and precision of the primary contrast from the registry entry alone. The posted p values should not be treated as measures of clinical importance.
General statistical context: statistical evidence addresses compatibility between data and a model or hypothesis; clinical importance concerns whether a difference matters in the relevant setting. A threshold for clinically meaningful change is not reported in the registry record. The record also does not provide enough information about missing data, multiplicity, model specification, or the analysis plan to evaluate the robustness of the reported findings fully.
The selected secondary summaries provide additional descriptive context, but they are unadjusted recalculations and do not replace sponsor analyses. Their intervals include zero, and the record does not report a multiplicity strategy for the broader outcome set. They therefore should not be read as proof of no differences, nor as independent confirmation of the primary result.
These results are specific to the registered 12-week study, its stated pediatric asthma population, treatment regimens, endpoint definition, and analysis population. They do not establish what would occur with different populations, durations, or treatment conditions. No treatment recommendation follows from these statistical summaries.
14. Why This Trial Matters Statistically
This trial illustrates why arm-level changes and treatment contrasts must be kept distinct. The registry reports least-squares mean changes with 95% confidence intervals for each group, while the comparative analyses are represented by p values without corresponding treatment-difference estimates or intervals. Readers can see the pattern of group estimates, but cannot assess the primary contrast’s size and precision from those summaries alone.
It also illustrates the importance of unambiguous reporting. Two listed mixed-model p values refer to the same Symbicort 80/4.5 µg versus budesonide comparison, yet the record does not explain their relationship. A clear analysis description would help readers identify which model and contrast support the principal comparison and how uncertainty was quantified.
The study’s multiple outcomes and analyses make prespecification and multiplicity procedures important. The registry lists many outcomes and analyses, but does not report an adjustment strategy or testing hierarchy. General statistical context: without that information, nominal p values across a broad set of tests should be interpreted cautiously. The issue is not that secondary outcomes are uninformative; rather, their inferential weight depends on the planned analysis and the total testing context.
Finally, the endpoint population is defined by treatment exposure and efficacy contribution, while the overall enrollment is a separate figure. Reporting the flow of participants, reasons for missing outcomes, model details, and sensitivity analyses would clarify how the available data support the estimates. These are general features of transparent trial reporting, and the registry record does not report them in the information available for this analysis.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the registry record for this trial. The primary endpoint is reported through group least-squares means and confidence intervals, but the record does not provide the treatment-difference estimates or confidence intervals needed to judge the magnitude and precision of the main comparisons. The mixed-model method is named, but its specification, covariates, repeated-measure structure, and missing-data assumptions are not reported.
The registry lists two different p values for the same Symbicort 80/4.5 µg versus budesonide comparison, with no explanation of whether these reflect different analyses or a record issue. The statistical analysis plan, multiplicity strategy, and prespecified status of the individual comparisons are not reported. The record also does not report interim analyses or the original sample-size justification.
The primary analysis population requires at least one dose and at least one efficacy endpoint contribution. Counts and reasons for missing primary measurements, participant disposition by group, adherence, and sensitivity analyses are not reported. These omissions make it difficult to evaluate the potential effect of missing data or departures from randomized assignment in practice.
The registry lists 13 secondary outcomes, but detailed numerical summaries described in the available record cover only a subset. The unadjusted recalculations for selected secondary outcomes are not equivalent to sponsor analyses and do not account for the broader testing context. For safety, serious-event counts are small, death counts are not reported, and the listed serious event terms are not clearly mapped to groups in the available information. These reporting limits do not establish bias or invalidate the results, but they constrain how confidently the record can support detailed comparative conclusions.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg — NCT02091986.
- Registry record last updated 2017-04-10; status last verified 2017-02.
- Results first posted 2017-04-10.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT02091986 is a completed Phase 3, randomized, quadruple-masked, parallel-group, multicenter study of children ages 6 to <12 years with asthma. It compared two Symbicort pMDI regimens with budesonide pMDI over 12 weeks. The registry reports enrollment of 882 and identifies AstraZeneca as sponsor.
The primary endpoint was change from baseline to Week 12 in 1-hour post-dose FEV1. Group least-squares mean changes were 0.28 liters, 0.24 liters, and 0.17 liters, with 95% confidence intervals reported for each group. Mixed-model p values are listed, including two different entries for the same 80/4.5 µg versus budesonide comparison.
The record does not report primary contrast estimates and intervals, detailed model specifications, a multiplicity strategy, the sample-size rationale, or missing-data sensitivity analyses. Selected secondary summaries and adverse-event counts offer additional descriptive information, but do not resolve those gaps.