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 Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED) (NCT00442351), a randomized phase 4 study. The primary outcome is Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00442351 |
| Phase | Phase 4 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 26 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with mild or moderate persistent asthma. The registry lists asthma as the condition and an enrollment of 26. It does not report further eligibility criteria, such as age limits, baseline lung-function requirements, or the permitted history of asthma treatment. The population to which any result might apply therefore cannot be characterized more precisely from this record.
Intervention
The planned treatment was Asmanex Twisthaler 220 mcg once daily in the evening. The brief summary describes a 12-week comparison. The record identifies this as maintenance treatment, but it does not provide details about adherence, dose changes, rescue medication, or other concurrent care. The registry status is terminated; that status alone does not explain how much treatment was received.
Comparator
The comparator was a placebo inhaler for Asmanex Twisthaler, also taken once daily in the evening. The study is described as placebo-controlled and double-blind. The record does not explain the matching procedure or whether masking was assessed. It identifies parallel groups, meaning the planned comparison assigned participants to one study arm rather than describing a crossover between treatments.
Primary question
The primary question was whether change from baseline to the final or terminal visit in morning office-measured forced expiratory volume in 1 second (FEV1) differed between the treatment and placebo groups over twelve (12) weeks. The record says this change was to be analyzed with ANCOVA. It does not report a treatment contrast, an uncertainty interval, a p-value, or any analyzed primary outcome data. Thus the registry record specifies the question, but does not answer it.
3. Trial Design
The registry describes NCT00442351 as a Phase 4, randomized, double-blind, parallel-group, placebo-controlled study sponsored by Organon and Co. It lists asthma as the condition and an enrollment of 26. The listed start is 2006-09 and the listed primary completion is 2007-04. The current status is TERMINATED. The record does not state why the study was terminated, whether termination occurred before or after the planned treatment period, or whether it was related to recruitment, conduct, safety, or any other circumstance.
The brief summary describes a multicenter comparison of Asmanex Twisthaler 220 mcg once daily in the evening against Asmanex placebo once daily in the evening for 12 weeks. Random allocation is intended to make the groups comparable on average at the start of a study, while masking is intended to limit the influence of treatment knowledge on care and outcome assessment. These are general features of trial design; the registry does not describe how randomization was generated, how assignment was concealed, or how the blind was maintained.
The registry lists one primary outcome measure: change from baseline to the final or terminal visit in morning office measurements of FEV1. The outcome timeframe is twelve (12) weeks. The description says baseline was assessed at the visit before randomization and that the change was to be analyzed using ANCOVA. No results analysis is listed, and no primary estimate or uncertainty measure appears in the record. The study design therefore supplies context for interpreting a comparison, but not evidence about the observed treatment difference.
The enrollment entry should not be mistaken for the number analyzed for the primary endpoint. The safety listings identify 17 people at risk in the Asmanex Twisthaler group and 9 in the placebo inhaler group, but the record does not explain the relationship between those listings, enrollment, randomization, completion, and the primary analysis population. Arm-specific descriptions are blank. Reasons for exclusions, discontinuations, or deviations from the planned treatment 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 | Asmanex Twisthaler | Placebo Inhaler |
|---|---|---|
| STARTED | 17 | 9 |
| COMPLETED | 10 | 3 |
| NOT COMPLETED | 7 | 6 |
Reasons for not completing this period:
| Reason | Asmanex Twisthaler | Placebo Inhaler |
|---|---|---|
| Administrative | 6 | 5 |
| Did not meet protocol eligibility | 1 | 0 |
| Other | 0 | 1 |
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 | Asmanex Twisthaler | Placebo Inhaler | Total |
|---|---|---|---|---|
| Participants analysed | 17 | 9 | 26 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 17 | 8 | 25 |
| Age, Categorical: >=65 years | Participants | 0 | 1 | 1 |
| Age, Continuous | years | 41.9 (SD 11.9) | 42.6 (SD 17.0) | 42.1 (SD 13.5) |
| Sex: Female, Male: Female | Participants | 10 | 7 | 17 |
| Sex: Female, Male: Male | Participants | 7 | 2 | 9 |
| Region of Enrollment: United States | participants | 17 | 9 | 26 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements., measured over Twelve (12) weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
FEV1 is the volume of air a person can forcefully exhale in the first second of an expiration. It is a measure of lung function, and change in FEV1 can be used as a physiologic outcome in asthma studies. This is general context for the endpoint, not a reported result from this trial.
The planned primary outcome was the change from the pre-randomization baseline visit to the final or terminal visit in morning office-measured FEV1. The timeframe is twelve (12) weeks. A change score describes how the measurement at follow-up differs from the participant’s baseline measurement; it is not the same as reporting only the follow-up value. The registry record does not provide the unit, the way measurements were summarized, or the specific visit data.
The record states that the change was to be analyzed with ANCOVA. In general, this approach can compare groups while accounting for baseline values, which may improve precision and address baseline imbalance. The registry does not give the full model specification, the estimated group difference, its confidence interval, or a p-value. Consequently, the endpoint definition explains what the trial intended to measure, but the posted registry information does not show the size or precision of any observed change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a clinical question and a planned analysis, but it does not report the result needed to assess that question. Although it lists one primary outcome measure and describes an ANCOVA model, the number of analyses listed is 0. No group-level FEV1 changes, treatment contrast, standard error, confidence interval, or primary-outcome p-value are reported. The record therefore does not establish the direction, magnitude, or precision of a difference in FEV1 between the study arms.
The absence of a reported primary result should not be read as evidence that the groups were the same, or as evidence that one group had a better result. A null or non-significant finding would require reported estimates and their uncertainty; none appears in this record. Likewise, the terminated status does not explain why the outcome result is unavailable. The reason for termination and any connection between termination and the analysis are not reported in the registry record.
The enrollment listing and safety-group listings provide context, but they do not fill this efficacy gap. The registry lists an enrollment of 26, while the safety listing reports 17 at risk in the Asmanex Twisthaler group and 9 at risk in the placebo inhaler group. The record does not explain the analysis populations or establish that all enrolled, randomized, treated, or analyzed participants are represented in the same way. No primary-outcome denominators are reported.
The record does report adverse-event counts, which must be interpreted separately from FEV1. Serious adverse events are listed as 0 in each arm. Other adverse events are listed as 5 in the Asmanex Twisthaler group and 3 in the placebo inhaler group. These are counts, not a comparative analysis; the record provides no uncertainty estimates or details about event types in the top serious-event terms. The safety counts do not answer the primary lung-function question.
For readers considering the planning illustrations, the registry’s methodological note describes an illustration based on a stated fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The primary outcome was not reduced to one comparison, so a single observed effect is not identified in the record. Such planning calculations are not observed power and cannot substitute for a reported trial analysis.
9. Statistical Methods Explained
The planned analysis is described as ANCOVA, or analysis of covariance. The registry says the baseline measurement was collected before randomization and that the change from baseline to the final or terminal visit was to be analyzed with this model. That is the extent of the model specification in the record. It does not identify additional covariates, the exact response variable coding, the estimation method, or any checks of model assumptions.
What does ANCOVA do?
In general, ANCOVA estimates a group comparison while accounting for one or more covariates. For a baseline-and-follow-up study, baseline outcome is commonly included as a covariate. Accounting for baseline can make the comparison more precise than comparing follow-up values alone, particularly when baseline values are related to follow-up values. This is a general explanation, not a claim about unreported model details. Here, the registry specifically names ANCOVA and describes a change-from-baseline endpoint, but does not state how baseline entered the model or whether other variables were included.
A treatment contrast from ANCOVA would ordinarily be reported with an estimate and an uncertainty measure. A confidence interval gives a range of values compatible with the data and the model at its stated confidence level; a narrower interval indicates greater precision, while a wider interval indicates less precision. A p-value addresses compatibility of the data with a specified null hypothesis under the analysis assumptions. Neither an interval nor a p-value for the primary endpoint is reported. Without the estimate and its uncertainty, the result cannot be judged for size, direction, or precision.
Why does randomization matter?
In general, random assignment helps balance both measured and unmeasured prognostic factors across study groups in expectation. It does not guarantee exact balance in a particular study, and it does not remedy missing outcomes, deviations from assigned treatment, or limitations in the recorded analysis. The registry identifies the allocation as randomized but does not give the sequence-generation method, allocation concealment details, or a baseline characteristics table. It is therefore possible to describe the intended design feature, but not to assess its implementation from this record.
What does masking contribute?
Double masking is intended to reduce the potential for expectations about treatment assignment to influence participant behavior, clinical management, or outcome assessment. Those protections depend on how masking was implemented and maintained. The record describes the study as double-blind, but does not say which roles were masked, whether treatment assignments were revealed, or whether masking was evaluated. The label alone cannot establish that bias was absent.
How should a planning calculation be understood?
In general, a sample-size calculation depends on a target effect, variability, a significance threshold, power, allocation, and the assumptions of the chosen statistical model. The registry methodological note describes a planning illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It distinguishes participants per arm for a non-time-to-event calculation from total events for a time-to-event calculation. These are planning conventions, not evidence that the trial was designed using those assumptions.
The record does not provide a single observed primary effect that can be used to interpret such an illustration. It explicitly indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Any planning illustration based on an observed effect should therefore not be treated as an analysis result or as a measure of the chance that the trial’s findings are correct. Sample-size calculations are planning illustrations, never observed power.
Why does the outcome structure matter?
A statistical analysis needs a clearly defined comparison: which participants, which visit or time point, which outcome summary, and which model contrast. The record’s description of a final or terminal visit and a twelve (12)-week timeframe does not supply the actual observed values or a single reported comparison. The registry’s note that the outcome was not reduced to one comparison further limits what can be inferred from planning calculations. It is not possible to reconstruct the analysis from the endpoint description alone.
General statistical interpretation also depends on assumptions about the data, such as the distribution of residuals and the relationship between the outcome and covariates. These are matters that an analysis may assess, but the registry record does not report diagnostic checks or remedial methods. No reanalysis can be justified from the summary information because the necessary outcome summaries and model results are absent. The proper reading is therefore descriptive: the intended method was ANCOVA, but its output is not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary outcome measure, but it also records that the outcome was not reduced to one comparison because it has several categories or time points. It does not specify which comparisons were considered primary for inference, whether there were additional outcome time points, or whether a hierarchy of comparisons was prespecified. A multiplicity adjustment or strategy is not reported in the registry record.
In general, multiplicity arises when several hypotheses or comparisons are examined: the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the set of tests. The relevant set of comparisons and any adjustment method need to be specified to interpret multiple p-values. Because no primary analysis results or complete comparison structure are listed, the registry does not allow an assessment of how multiplicity was handled.
Missing-data methods are also not described. The record does not report the number of missing FEV1 measurements, reasons for missingness, the handling of incomplete follow-up, or any imputation or sensitivity analysis. It does not identify an intention-to-treat, per-protocol, or other analysis population for the primary outcome. These omissions matter because the population analyzed and the handling of missing outcomes can affect both the estimate and its uncertainty. The registry record does not report enough detail to determine whether all randomized participants contributed to the primary analysis or how departures from the planned schedule were addressed.
The record’s terminated status does not resolve these questions. The reason for termination, the status of planned analyses, and any interim analyses are not reported in the registry record. No assumptions about the protocol or the analysis plan can be made from the termination label alone.
11. 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 |
|---|---|---|---|
| Asmanex Twisthaler | 0 | 17 | 0.0% |
| Placebo Inhaler | 0 | 9 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Asmanex Twisthaler | 5 of 17 |
| Placebo Inhaler | 3 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Asmanex Twisthaler | Placebo Inhaler |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 1 of 17 | 2 of 9 |
| Pyrexia | General disorders | 1 of 17 | 0 of 9 |
| Acute sinusitis | Infections and infestations | 1 of 17 | 0 of 9 |
| Oral candidiasis | Infections and infestations | 1 of 17 | 0 of 9 |
| Headache | Nervous system disorders | 1 of 17 | 0 of 9 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 17 | 1 of 9 |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 17 | 1 of 9 |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | 1 of 17 | 0 of 9 |
| Scar excision | Surgical and medical procedures | 1 of 17 | 0 of 9 |
The safety listings report serious adverse events for each group. The Asmanex Twisthaler group has 0 serious adverse events among 17 at risk, and the placebo inhaler group has 0 among 9 at risk. These are the posted counts; they are not evidence that serious harms are impossible or that the groups have identical safety profiles. The record provides no uncertainty intervals or detailed information about follow-up completeness.
For other adverse events, the listing reports 5 in the Asmanex Twisthaler group among 17 at risk and 3 in the placebo inhaler group among 9 at risk. These figures should be read as recorded counts, not as a comparative effect estimate. The registry does not provide event descriptions, severity breakdowns, timing, exposure duration by participant, or a statistical comparison. The groups’ listed at-risk sizes differ, and the counts alone do not establish whether the underlying risks differ.
Deaths are not reported in the registry record. The listing of 0 serious adverse events should not be interpreted as a death count. Safety findings also cannot replace the missing primary FEV1 result, and the record does not state whether the reported adverse-event counts cover the full planned treatment period.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-blind, placebo-controlled study was planned to compare evening Asmanex Twisthaler with an Asmanex placebo inhaler in mild or moderate persistent asthma. It identifies change in morning office-measured FEV1 as the primary outcome and describes an ANCOVA analysis. It also lists an enrollment of 26, a 12-week treatment period, and a terminated status. These details explain the planned question and its context.
What the record does not establish is the answer to that question. No primary FEV1 results, between-group estimate, confidence interval, or p-value are reported. It is therefore not possible to tell from the posted results whether the groups differed, how large any difference was, or how precisely it was estimated. This absence should not be converted into a claim of no difference or a claim of benefit.
The safety entries are narrower in scope. They list 0 serious adverse events in each group, alongside counts of other adverse events. Those counts do not establish a comparative safety effect, and deaths are not reported in the registry record. The available detail is insufficient to assess event types, timing, or exposure-adjusted comparisons.
In general, randomized design and masking can strengthen the interpretation of a well-reported comparison, but they do not supply missing results or analysis details. The terminated status likewise does not identify the reason for termination or the completeness of outcome reporting. The most defensible conclusion is limited: the registry describes the study’s intended comparison and some safety counts, while leaving its primary efficacy result and important analysis details unavailable.
13. Why This Trial Matters Statistically
This trial matters statistically because the registry distinguishes a planned clinical comparison from a reported estimate. A recognizable design, a defined endpoint, and a named analysis method do not by themselves show what the observed data indicate. For the primary question, an estimate and its uncertainty are essential. Their absence means that the treatment comparison cannot be interpreted for direction, magnitude, or precision.
The record also illustrates why enrollment, analysis populations, and endpoint results should not be treated as interchangeable. It lists an enrollment of 26 and safety-group counts, but does not explain which participants contributed to the primary outcome analysis. Without a participant flow account or outcome denominators, the completeness of the efficacy data cannot be evaluated. These details are part of assessing the reliability and generalizability of a trial result.
There is a further lesson about planning calculations. A planning illustration based on an observed effect is not a substitute for the observed effect and does not establish observed power. Here, the methodological note states that the primary outcome was not reduced to one comparison. That makes it especially important to identify the comparison and analysis that would support an interpretable estimate, rather than treating a planning exercise as a result.
Finally, the terminated status and sparse reporting demonstrate the importance of transparent reporting of reasons for study status, analysis populations, missing data, and planned comparisons. Those details would help readers understand what was completed and how the results should be interpreted. Since they are not reported in the registry record, conclusions must remain confined to the design description and the limited posted safety counts.
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 main limitation for interpretation is that the registry record does not report the primary FEV1 analysis. There is no estimate of change by group, treatment contrast, confidence interval, or p-value. As a result, neither the size nor the precision of the primary comparison can be assessed. The record identifies a planned endpoint and analysis but does not provide the outcome data needed to evaluate them.
The registry lists TERMINATED as the study status, but the reason for termination is not reported in the registry record. The timing and circumstances of the decision, the extent of study completion, and whether any planned analyses were performed are also not reported. No conclusion about these matters should be drawn from status alone.
Further limitations include the lack of a detailed participant flow, primary analysis population, missing-data methods, and full statistical model specification. The record does not describe randomization procedures or how masking was implemented. Baseline characteristics, adherence, treatment discontinuations, and the handling of protocol deviations are not reported in the registry record. These gaps limit evaluation of potential bias and applicability.
Safety information is also limited to counts. Serious adverse events are listed as 0 in both groups, other adverse-event counts are listed, and deaths are not reported in the registry record. Event descriptions, timing, and a formal comparative analysis are unavailable. The registry’s note that the primary outcome was not reduced to one comparison also leaves the relevant comparison structure unclear. Taken together, these limitations mean the record supports description of the intended study, but not a substantive estimate of treatment effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED) — NCT00442351.
- Registry record last updated 2022-02-09; status last verified 2022-02.
- Results first posted 2010-04-16.
- 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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18. Record Summary
NCT00442351 is listed as a Phase 4 randomized, double-blind, parallel-group, placebo-controlled study of Asmanex Twisthaler 220 mcg once daily in the evening versus placebo in mild or moderate persistent asthma. The planned duration was 12 weeks, and the primary outcome was change from baseline to the final or terminal visit in morning office-measured FEV1, analyzed using ANCOVA. The registry lists an enrollment of 26 and a status of TERMINATED.
No primary outcome analysis is listed, and no efficacy estimate or uncertainty measure is reported. Safety listings report 0 serious adverse events in each group; other adverse-event counts are 5 and 3, with deaths not reported in the registry record. The reason for termination, analysis populations, missing-data methods, and detailed statistical plan are not reported in the registry record.