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 Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia (NCT00576316), a non-randomized phase 4 study. The primary outcome is Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00576316 |
| Phase | Phase 4 |
| Condition | Asthma |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 201 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
People with asthma were recruited for a study described as taking place in a real-life setting in Malaysia. The registry record reports 201 participants recruited and says statistical analysis was completed for 195 participants. It does not give further eligibility criteria or describe the characteristics of the participants.
Intervention
Participants were treated with Symbicort SMART using Symbicort Turbuhaler 160/4.5. The stated purpose was to evaluate patient satisfaction with this approach to asthma management. The registry record does not describe additional treatment procedures or how treatment use was managed during follow-up.
Comparator
There was no separate randomized control group. The study used a single-group design, and the primary outcome compares each participant’s baseline satisfaction score with a later score. This within-participant baseline comparison is not the same as a comparison against an untreated group or another treatment.
Primary question
The primary question was whether SATQ scores changed from baseline to the mean of the measurements taken 3 months and 6 months after each participant was initially treated with SMART. The SATQ is a patient-reported questionnaire; higher scores indicate greater satisfaction. The registry record does not report the numerical change, its direction, or its uncertainty.
3. Trial Design
The registry identifies the study as a completed Phase 4 trial, titled “Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia.” AstraZeneca is listed as the sponsor, and the recorded start is 2008-01. Asthma is the listed condition. The stated purpose was to evaluate satisfaction among patients using the Symbicort SMART approach for asthma management.
The design is listed as non-randomized, unmasked, and single-group. These features mean that the primary comparison is a change within participants over time rather than a contrast between concurrently assigned treatment groups. The registry record does not describe a randomized allocation process, blinding, or a control arm. It also does not report a protocol-level explanation for choosing this design.
The intervention is listed as Symbicort Turbuhaler 160/4.5. The primary outcome is a change in SATQ scores, evaluated from baseline to the mean of the 3-month and 6-month measurements after initial treatment. The description says the change was analysed with a paired t-test. An ACQ-5 score change over baseline and follow-up is listed as a secondary outcome.
The registry reports 201 participants recruited and statistical analysis completed for 195 participants. It does not explain the difference between the recruited and analysed counts, specify the analysis population in more detail, or report how missing measurements were handled. The record lists two outcome measures and zero analyses. Detailed recruitment procedures, eligibility criteria, follow-up procedures, and sample-size justification are not reported in the registry record.
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.
Overall Study
| Stage | Symbicort 160/4.5 Turbuhaler |
|---|---|
| STARTED | 201 |
| COMPLETED | 181 |
| NOT COMPLETED | 20 |
Reasons for not completing this period:
| Reason | Symbicort 160/4.5 Turbuhaler |
|---|---|
| Adverse Event | 9 |
| Withdrawal by Subject | 2 |
| Protocol Violation | 9 |
Analysis population for the primary outcome, as defined in the registry: 201 participants were recruited but statistical analysis was completed for 195 participants
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.
| Characteristic | Unit | Symbicort 160/4.5 Turbuhaler |
|---|---|---|
| Participants analysed | 201 | |
| Age Continuous: Mean Age | years | 46.73 (SD 12.31) |
| Sex: Female, Male: Female | Participants | 155 |
| Sex: Female, Male: Male | Participants | 46 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART, measured over 6 months after each patient was initially treated with Symbicort SMART.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Scores on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Satisfaction With Asthma Treatment Questionnaire (SATQ) score. The registry describes the comparison as baseline versus the mean of the measurements taken 3 months and 6 months after a participant was initially treated with SMART, with a timeframe of 6 months after initial treatment. The stated analysis was a paired t-test.
The SATQ is described as a patient-reported questionnaire consisting of 26 questions and scored on a scale of 1-7. Higher scores indicate greater satisfaction. A patient-reported measure can capture participants’ own assessment of their treatment experience, which is relevant to a study whose stated purpose is to evaluate satisfaction. The score is continuous, and the registry lists the endpoint parameter as a mean with standard deviation as its dispersion measure.
Interpreting a change score requires knowing its estimated size and direction, along with information about its uncertainty. Those numerical results are not reported in the registry record. The endpoint description therefore clarifies what was intended to be measured and how, but it does not establish whether scores changed, how large any change was, or how precisely it was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a satisfaction endpoint and a paired analysis, but it does not provide the numerical SATQ result. There is no reported mean change, standard deviation for the change, confidence interval, or p-value. As a result, the direction and magnitude of the primary outcome cannot be assessed from the registry record, nor can its statistical precision be described. The endpoint’s scoring direction is stated: higher SATQ scores indicate greater satisfaction. That information alone does not reveal whether the observed scores increased or decreased.
The study’s single-group design matters for interpretation. A baseline-to-follow-up comparison describes change over time among participants with measurements; it is not a randomized comparison of SMART with another treatment or with no treatment. Without a concurrent comparison group, changes cannot be separated from other influences that may occur over time. This is a general limitation of within-group change analyses, not evidence that any particular alternative explanation occurred in this study.
The registry reports 201 participants recruited and says statistical analysis was completed for 195 participants. It does not state why these counts differ or whether the analysed participants represent everyone recruited. The presence of a paired analysis makes the handling of participants without complete paired measurements important, but the registry record does not describe missing-data methods or the exact analysis population. These omissions limit assessment of how representative the reported analysis would be, even if outcome estimates were available.
The record lists ACQ-5 score change as a secondary outcome, but it does not report its result either. It lists two outcome measures and zero analyses. The registry record therefore does not allow readers to assess the consistency of primary and secondary outcomes or determine whether analyses were adjusted for examining multiple outcomes. Such adjustment is not reported in the registry record.
Safety information is also incomplete for estimating event frequency. The record lists 17 serious adverse events and 70 other adverse events for the Symbicort group, but the number at risk is not reported. It also lists serious-event terms with percentages, including Asthma at 7.7% and Upper Respiratory Tract Infection at 2.6%; the basis for those percentages is not specified in the registry record. Deaths are not reported in the registry record. These entries should not be interpreted as comparative risks, since the study has no listed control group and the relevant denominators are unavailable.
In general, a confidence interval communicates the range of values compatible with an estimate under the assumptions of the analysis. No confidence interval for the primary change is reported, so its precision cannot be characterized. The registry’s description of an analysis method is not a substitute for the estimate and its uncertainty. The posted information supports a description of the question and design, but not a conclusion about the size or statistical evidence of SATQ change.
9. Statistical Methods Explained
The primary outcome is continuous: SATQ scores are measured on a scale, and the registry specifies a mean as the parameter of interest. The endpoint is defined as a change from baseline to the mean of measurements taken 3 months and 6 months after initial treatment. The registry says this change was analysed using a paired t-test.
What does a paired t-test assess?
In general, a paired t-test evaluates the average within-participant difference between two measurements. Pairing is useful when the same participants contribute both measurements because each participant serves as their own reference. The method focuses on the distribution of participant-level differences, rather than treating baseline and follow-up observations as if they came from unrelated groups. For this study, the registry’s endpoint description identifies the baseline score and a follow-up value formed from the mean of the 3-month and 6-month scores.
In general, a paired t-test assumes that participant-level differences are independent across participants and that their distribution is sufficiently compatible with the test’s normality assumption for the inference to be appropriate. The registry record does not report diagnostic checks, a distributional assessment, or a sensitivity analysis. It also does not report how the follow-up mean was calculated when one of the two later measurements was unavailable.
Why is the result needed alongside the method?
A test name does not convey the size or direction of an effect. To interpret a continuous outcome, readers need an estimate of change and a measure of its uncertainty. A p-value, if reported, would address compatibility with a specified null hypothesis under the model assumptions; it would not by itself express the magnitude or practical importance of a change. The registry record does not report a primary estimate, confidence interval, or p-value, so none of these aspects can be evaluated.
In general, a confidence interval combines an estimate with its sampling uncertainty. A narrower interval indicates greater precision under the assumptions used, while a wider interval indicates less precision. It would not show that the design has ruled out bias or confounding. No confidence interval is reported for this endpoint.
How does the design shape the analysis?
This is a non-randomized, unmasked, single-group study. The paired analysis uses within-participant measurements, but it does not create a comparison group. In general, a before-and-after analysis can describe change in the observed participants; by itself, it cannot distinguish the influence of treatment from other factors that may coincide with the passage of time. The registry record does not report additional methods intended to address such factors.
The registry describes 201 participants recruited and statistical analysis completed for 195 participants. It does not explain the difference in these counts, state whether all analysed participants had complete SATQ measurements, or identify any imputation or other missing-data procedure. In general, excluding participants without complete paired measurements can affect the analysis if inclusion is related to outcome or participant characteristics. Whether that concern applies cannot be assessed from the registry record.
What can be inferred from the planning assumptions?
In general, a sample-size planning illustration uses assumptions about a target effect, error rate, allocation, and statistical model to estimate a required sample size. The stated planning assumptions for illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect expressed as a fraction of the observed effect. For time-to-event outcomes, the stated illustration concerns total events; for other outcomes, it concerns participants per arm.
Those assumptions are described as planning illustrations rather than as the trial’s own design. The actual study is single-group, so a hypothetical two-arm allocation is not a description of its observed design. The registry record does not report a sample-size justification for SMARTER. Nor does the record provide an observed SATQ effect from which to judge the planning illustrations. Such illustrations are not observed power, and they cannot establish the probability that this study detected an effect.
What about variability and other outcomes?
The registry identifies standard deviation as the dispersion measure for the continuous primary outcome. In general, standard deviation describes variation among measurements; it is not the same as the uncertainty around an estimated mean. The registry record does not report the SATQ standard deviation or the standard deviation of participant-level changes. Without those values and the estimated change, the precision of the endpoint cannot be reconstructed from the record.
An ACQ-5 change is listed as a secondary outcome. The registry record does not report the numerical result or its analysis method. It also lists two outcome measures and zero analyses. No multiplicity procedure is reported. In general, examining multiple outcomes raises questions about how chance findings are interpreted, especially when inferential tests are conducted. The record does not state whether such tests were planned or adjusted.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Symbicort 160/4.5 Turbuhaler | 195 | 0.370 | 0.730 | 0.267 to 0.473 |
R code and output
arm <- c("Symbicort 160/4.5 Turbuhaler")
n <- c(195)
m <- c(0.37)
sp <- c(0.73)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM Symbicort 160/4.5 Turbuhaler 195 0.370 0.730 0.267 0.47311. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures: the primary SATQ change and a secondary ACQ-5 change. It lists zero analyses. The primary outcome description specifies a paired t-test, but no numerical analysis result is reported. The record does not describe a multiplicity adjustment, a hierarchy among outcomes beyond identifying the primary outcome, or a plan for interpreting multiple statistical tests. Whether any adjustment was used is not reported in the registry record.
For missing data, the record states that 201 participants were recruited and that statistical analysis was completed for 195 participants. It does not explain why the counts differ, report how many participants had complete measurements at each time, or describe exclusions, imputation, or sensitivity analyses. The specific analysis population and the handling of missing SATQ or ACQ-5 measurements are not reported in the registry record.
These omissions matter because a paired comparison requires usable measurements for the within-participant contrast being analysed. In general, missingness can affect both the number of participants contributing to an estimate and the interpretation of that estimate, depending on why measurements are unavailable. The registry record does not provide information to assess the relevant missingness assumptions.
No protocol-level statistical analysis plan, sample-size justification, interim-analysis plan, or account of deviations from planned analyses is reported in the registry record. The record’s description of the paired t-test and endpoint does not resolve these questions.
12. What the Result Does, and Does Not, Mean
The registry record establishes that SMARTER was designed to assess patient-reported satisfaction in a single group of people with asthma using Symbicort SMART. The primary endpoint was a change in SATQ score between baseline and a follow-up value based on measurements at 3 months and 6 months. Higher SATQ scores indicate greater satisfaction, and the stated analysis was a paired t-test.
The record does not report the numerical SATQ change or its uncertainty. It therefore does not establish whether satisfaction scores increased, decreased, or remained similar, and it does not show how precisely any change was estimated. The listed ACQ-5 secondary outcome also has no numerical result in the registry record. Descriptions of intended measures and methods should not be mistaken for reported findings.
The single-group design supports a within-participant description, not a randomized treatment contrast. In general, observed change over time in a single group may reflect treatment exposure alongside other influences, and the design alone cannot separate those contributions. This does not establish that any particular influence affected participants in this study.
The safety entries should also be read within their limits. The registry lists 17 serious adverse events and 70 other adverse events, but does not report the number at risk. It lists serious-event terms and percentages, without specifying the percentage denominator. These entries do not provide a comparative safety estimate. Deaths are not reported in the registry record.
Overall, the record supports a description of the study question, design, endpoint, and stated analysis method. It does not support a conclusion about the size, direction, statistical significance, or clinical importance of the primary result. The registry record does not report enough information to assess missing-data handling, multiplicity, or the precision of the outcome estimates.
13. Why This Trial Matters Statistically
This study illustrates a common distinction in clinical statistics: a clearly named endpoint and analysis method do not, on their own, communicate an outcome. The SATQ is patient-reported and its scoring direction is stated, which clarifies what the measure is intended to capture. Yet without the estimated change and its uncertainty, readers cannot assess the observed pattern or its precision.
The single-group design also makes the estimand important. A paired analysis can compare measurements from the same participants and account for their pairing, but it does not provide a randomized between-group contrast. This distinction is relevant when interpreting any change over time: a within-person change and a treatment effect relative to a comparator are different statistical questions.
The difference between the number recruited and the number included in statistical analysis raises an additional reporting question. The record does not explain the participant flow or missing-data approach. Transparent reporting of analysis populations and missing measurements helps readers understand which participants contribute to an estimate and what assumptions support it.
Finally, the record lists safety events without denominators and outcome measures without numerical results. Such entries identify what was recorded, but they do not permit complete assessment of event frequency or endpoint precision. For statisticians and clinical researchers, SMARTER therefore highlights the value of reporting estimates, uncertainty, analysis populations, and the basis for adverse-event percentages alongside study design and outcome definitions.
14. 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.
The primary limitation for interpreting results from the registry record is that the numerical SATQ outcome is not reported. The mean change, variability, confidence interval, and p-value are absent. The record therefore does not permit assessment of the endpoint’s direction, magnitude, or precision. The ACQ-5 secondary outcome is listed, but its numerical result is also not reported.
The study is non-randomized, unmasked, and single-group. There is no separate control group listed, so the baseline comparison cannot provide a randomized contrast. The registry record does not describe methods for addressing other influences on change over time. This limits causal interpretation of any within-participant change.
The participant counts are not fully explained. The record reports 201 participants recruited and statistical analysis completed for 195 participants but does not describe the reason for the difference, the analysed population in detail, or the handling of missing measurements. It also does not report whether the paired analysis required complete data at each stated follow-up measurement.
Safety reporting is limited by the absence of denominators for the listed counts and an unspecified basis for the serious-event percentages. Deaths are not reported in the registry record. The registry also does not report a sample-size justification, interim analyses, a multiplicity plan, or a detailed statistical analysis plan. These limitations concern the completeness of the registry record and should not be treated as evidence that an unreported procedure did or did not occur.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia — NCT00576316.
- Registry record last updated 2010-12-16; status last verified 2010-11.
- Results first posted 2009-12-29.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
SMARTER is a completed Phase 4, non-randomized, unmasked, single-group study sponsored by AstraZeneca, with a recorded start of 2008-01. It concerns asthma and the Symbicort SMART approach in a real-life setting in Malaysia. The registry reports 201 participants recruited and statistical analysis completed for 195 participants.
The primary endpoint is change in SATQ score from baseline to the mean of measurements at 3 months and 6 months after initial treatment, with a paired t-test specified. The SATQ has 26 questions, uses a scale of 1-7, and higher scores indicate greater satisfaction. Change in ACQ-5 score is listed as a secondary outcome.
The registry record does not report numerical results for either outcome, explain the participant-count difference, or describe missing-data or multiplicity methods. It lists 17 serious adverse events and 70 other adverse events, without numbers at risk. The record does not report deaths.