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 Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101) (NCT00306163), a randomized phase 3 study. The primary outcome is PC20 AMP (Post-treatment Compared to Baseline).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00306163 |
| Phase | Phase 3 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 37 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 18–60 years with stable asthma. The registry record states that analyses of treatment effects were performed on subjects who reached PC20 <640mg/mL; it does not report how many participants met that analysis-population criterion.
Intervention
Ciclesonide 160 µg, inhaled once daily at one dose level. The study description identifies treatment with ciclesonide during a five-week treatment period following a five-week baseline period.
Comparator
Fluticasone 100 µg, inhaled twice daily at one dose level. The comparator was administered in a parallel treatment group.
Primary question
How did the mean change from baseline in AMP PC20 after treatment compare between the ciclesonide and fluticasone groups, using AMP aerosols with small and large particle sizes? The registry record does not report the results needed to answer this comparison.
The trial focused on bronchial responsiveness in adults with stable asthma. PC20 AMP is the provocative concentration of adenosine-5'-monophosphate associated with a 20 percent decrease in FEV1. The stated outcome compares post-treatment measurements with baseline measurements and distinguishes aerosol particle size. For the small-particle condition, the mass mean aerodynamic diameter was approximately 1.04-1.08 micron; for the large-particle condition, it was approximately 9.9-10.6 micron.
The clinical question is therefore about a measured change in airway responsiveness under the two treatment regimens, with particle size part of the outcome description. It is not simply a comparison of the medicines in general: the record specifies doses, dosing frequency, a stable-asthma population, and a defined treatment period. It also lists safety and tolerability as a secondary outcome. The registry record does not report numerical primary outcome results, uncertainty estimates, or a formal comparison between treatments, so the direction and precision of any observed difference cannot be established from the reported results.
3. Trial Design
The registry identifies this as a Phase 3, randomized, triple-masked, parallel-group trial of ciclesonide and fluticasone in adults with asthma. Its recorded enrollment is 37. The study status is completed. The record lists AstraZeneca as sponsor, with a start date of 2006-05 and primary completion in 2008-08.
The arms are described as ciclesonide 160 µg and fluticasone 100 µg. The brief summary specifies once-daily inhalation for ciclesonide and twice-daily inhalation for fluticasone, each at one dose level. The study duration is described as a five-week baseline period followed by a five-week treatment period. The primary outcome timeframe is stated as baseline and 5 weeks.
Randomization indicates that assignment to study groups was intended to be determined by chance. Triple masking means that the registry classifies the study as masked at three levels, but it does not identify those roles or provide further masking procedures. The parallel model indicates that participants were assigned to a treatment group rather than described as crossing between treatments. The allocation sequence, concealment procedures, and specific identities of the masked groups are not reported in the registry record.
The objective was to compare lower-airway responsiveness after treatment, with AMP challenge measurements made using small and large aerosol particles. Safety and tolerability were also included among the stated study aims and outcomes. The registry record does not give a sample-size justification, detailed protocol, or account of deviations from the planned design. Enrollment and completion status describe the study record; they do not establish how many participants contributed to each primary outcome analysis.
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: A total of 101 subjects gave Informed Consent. 64 subjects did not enter or discontinued the study due to various reasons.
Overall Study
| Stage | Ciclesonide | Fluticasone |
|---|---|---|
| STARTED | 19 | 18 |
| COMPLETED | 19 | 18 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analyses on treatment effects were performed on all subjects who reached a PC20\<640mg/mL.
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 | Ciclesonide | Fluticasone | Total |
|---|---|---|---|---|
| Participants analysed | 19 | 18 | 37 | |
| Age, Continuous | years | 39.61 (inter quartile range 10.50) | 46.02 (inter quartile range 9.80) | 42.25 (inter quartile range 10.16) |
| Gender: Female | Participants | 13 | 8 | 21 |
| Gender: Male | Participants | 6 | 10 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as PC20 AMP (Post-treatment Compared to Baseline), measured over Baseline and 5 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Logarithm (mg/mL) |
| Endpoint classification | Continuous Endpoint |
The primary outcome is PC20 AMP, expressed as a logarithm in mg/mL, and described as the mean change between post-treatment and baseline. PC20 is the provocative concentration of adenosine-5'-monophosphate that leads to a 20 percent decrease in forced expiratory volume in one second (FEV1). The endpoint is intended to quantify airway responsiveness to an AMP challenge rather than to record a general symptom score.
The outcome description separates measurements made with small and large aerosol particles. Small particles are described as having a mass mean aerodynamic diameter of approximately 1.04-1.08 micron, while large particles are approximately 9.9-10.6 micron. Thus, particle size is part of the measurement context, not a separate treatment assignment described in the record.
In general, a change from baseline can help describe how a continuous measurement differs after treatment from its starting value. A mean summarizes the average change in the analyzed group, while a standard deviation describes the spread of individual measurements around that mean. The registry record names the mean and standard deviation but does not report their numerical values for either group or particle-size condition. It also does not report a between-group estimate or confidence interval. Consequently, the endpoint definition is clear, but the magnitude and precision of the observed treatment contrast are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically focused comparison: mean change in log PC20 AMP from baseline after treatment with ciclesonide or fluticasone, with results distinguished by AMP particle size. However, the primary outcome description is not accompanied by numerical outcome results. There is no reported group mean change, standard deviation, treatment contrast, confidence interval, or p-value. The magnitude, direction, and statistical precision of the primary comparison therefore cannot be interpreted from this record.
The enrollment entry is 37, but it should not be treated as the number contributing to every outcome. The record states that treatment-effect analyses were performed on subjects who reached PC20 <640mg/mL. It does not report the number meeting that criterion or the number analyzed in each group and particle-size condition. The available safety group counts are not a substitute for primary-outcome analysis counts.
The outcome description includes measurements using small and large particles, and the registry coding notes that the primary outcome has several categories or time points and was not reduced to one comparison. This means a reader should not infer that a single result represents all of the described measurements. The record does not specify a selected primary contrast or explain how the multiple conditions were interpreted. It also reports no analyses in the registry analysis count. No conclusion about whether the treatment groups differed, or how reliably any difference was estimated, can be drawn from the listed endpoint definition alone.
In general, a confidence interval communicates the range of effect estimates that are compatible with the data under the analysis assumptions. Without a reported estimate and interval, neither the direction nor the degree of uncertainty is available. A p-value, even if it had been reported, would not by itself describe the size or practical importance of a difference; no p-value is reported.
The registry record identifies a randomized, masked, parallel-group design, but those design features do not fill in missing outcome results. Nor does completion status establish that the intended comparison was statistically conclusive. The record also mentions safety and tolerability, yet these entries should be read as recorded event counts rather than as evidence about comparative efficacy. The appropriate statistical reading is limited: the trial question and endpoint are described, but the posted results do not report the primary numerical findings needed to answer that question.
9. Statistical Methods Explained
The registry describes a continuous primary outcome summarized as a mean with standard deviation. These summaries are commonly used when an endpoint is measured on a numerical scale. The mean gives a center for the observed values, while the standard deviation describes how dispersed those values are around the mean. Neither statistic is reported numerically for the primary endpoint in this record, so the shape and variability of the measurements cannot be assessed from the entry.
What does the change from baseline represent?
The endpoint is defined as the post-treatment value compared with baseline, on a logarithmic PC20 AMP scale. In general, change-from-baseline analysis focuses on how a measurement shifts relative to its starting value. This can be useful when baseline measurements vary between people, but interpretation depends on the precise analysis specification and reported estimates. The registry gives the intended comparison but does not report the calculation details, group summaries, or an adjusted or unadjusted treatment contrast. It is therefore not possible to determine how the change was modeled or whether baseline values entered the analysis in another way.
Why does particle size matter to the endpoint description?
The outcome description distinguishes small particles, with MMAD approximately 1.04-1.08 micron, from large particles, with MMAD approximately 9.9-10.6 micron. These are measurement conditions for the AMP challenge. In general, an outcome measured under different conditions may yield multiple related results rather than a single summary. The registry notes that the primary outcome has several categories or time points and was not reduced to one comparison. No numerical results for the separate particle-size conditions are reported.
What would a treatment contrast and confidence interval add?
In general, a treatment contrast expresses the estimated difference between groups under a specified analysis. A confidence interval conveys uncertainty around that estimate, conditional on the statistical model and its assumptions. Together, they help readers judge both the estimated size and precision of a group difference. The registry record does not report a primary treatment contrast or confidence interval. There is consequently no basis for describing the estimated effect as large, small, precise, or imprecise.
How should significance testing be understood?
In general, a p-value evaluates how compatible the observed data are with a specified null model, given the analysis assumptions. It does not measure the probability that a treatment works, and it does not describe the size of an effect. The record does not report a p-value, the test used, or the null hypothesis for a primary comparison. The statistical analysis plan, including any model, covariates, or rules for selecting among particle-size results, is not reported in the registry record.
What does randomization contribute?
In general, random allocation is used to reduce systematic differences between treatment groups at the point of assignment. It does not guarantee that all observed characteristics are balanced, particularly in a modest-sized study, and it does not remove the need to report group results and uncertainty. Here the registry classifies the study as randomized, but details about sequence generation and allocation concealment are not reported. Triple masking is recorded, although the specific masked parties and procedures are also not reported.
What can the analysis population tell us?
The registry states that analyses on treatment effects were performed on all subjects who reached PC20 <640mg/mL. This gives a threshold-based description of the analysis population, but not a count or a complete definition of who contributed to each endpoint condition. The analysis population should not be assumed to be identical to the enrolled group or to the groups used for safety summaries. The registry record does not report participant flow, exclusions, missing endpoint measurements, or whether any alternative analysis populations were used.
What about dispersion and distributional assumptions?
In general, variability matters because a mean difference can be estimated less precisely when measurements are widely dispersed. Statistical methods for continuous outcomes also rely on assumptions about the data or model errors; departures from those assumptions may affect uncertainty estimates. The registry specifies standard deviation as the dispersion measure but does not report the values, distribution checks, or analytic method. There is no basis to assess whether a normal approximation or another method was used for the primary outcome. The record's sample-size assumptions describe planning illustrations using a normal approximation and a two-sided significance level of 0.05; these are not a report of the trial's own statistical plan.
These general concepts clarify what the listed endpoint and design could support, but they do not replace missing trial-specific estimates. The registry record does not report sufficient numerical outcome information to reproduce or independently evaluate the primary treatment comparison.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes multiple measurement conditions or time points, and the registry coding indicates that it was not reduced to one comparison. That matters because testing several related outcomes can raise a multiplicity question: if multiple hypotheses are evaluated, the overall chance of a false-positive finding can differ from the chance associated with a single planned test. In general, trial protocols may address this through a prespecified hierarchy, adjustment, or another strategy. The approach used in this study is not reported in the registry record.
The registry does not report a statistical analysis plan, a primary contrast selected from the particle-size conditions, or an adjustment for multiple testing. It also does not report the primary outcome estimates or tests. As a result, no claim about statistical significance or control of multiplicity can be evaluated from the record.
Missing-data handling is not reported in the registry record. The entry does not describe how unavailable baseline or post-treatment PC20 measurements were handled, whether participants withdrew from outcome assessment, or whether any imputation or sensitivity analysis was used. Those details matter because analyses can depend on which measurements are available and on assumptions about why data are missing.
The stated treatment-effect population consists of subjects who reached PC20 <640mg/mL. The record does not report the number meeting that threshold, the number analyzed for each condition, or whether other analysis populations were considered. The enrollment entry of 37 does not establish the primary endpoint denominator. A sample-size justification and the trial's prespecified statistical plan are not reported in the registry record. Planning illustrations based on an observed effect are not a substitute for those design details and should not be interpreted as observed power.
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 |
|---|---|---|---|
| Ciclesonide | 0 | 19 | 0.0% |
| Fluticasone | 0 | 18 | 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 |
|---|---|
| Ciclesonide | 2 of 19 |
| Fluticasone | 2 of 18 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ciclesonide | Fluticasone |
|---|---|---|---|
| Urticaria | Skin and subcutaneous tissue disorders | 1 of 19 | 0 of 18 |
| Common cold | Infections and infestations | 1 of 19 | 0 of 18 |
| Pain armpit | General disorders | 0 of 19 | 1 of 18 |
| Inflammation of the throat | Respiratory, thoracic and mediastinal disorders | 0 of 19 | 1 of 18 |
The registry lists serious adverse events for the ciclesonide group as 0 affected among 19 at risk, and for the fluticasone group as 0 affected among 18 at risk. These are the recorded serious adverse event counts in the entry. The serious-event term list is empty. The deaths entries are null, which means a death count is not reported in the registry record; null should not be read as a reported zero.
For other adverse events, the record lists 2 affected among 19 at risk in the ciclesonide group and 2 affected among 18 at risk in the fluticasone group. These are descriptive counts. They do not by themselves establish whether the groups differed in risk, because the record does not provide an inferential comparison, uncertainty estimates, event descriptions, or exposure-adjusted analyses.
In general, adverse-event counts depend on how events were defined, collected, and attributed, and on the period of observation. The registry record does not give further detail on those procedures or specify the seriousness criteria. The figures should therefore be read as registry entries for this study, not as a complete account of safety or as evidence that events were or were not related to treatment. Safety and tolerability were stated study aims, but the available entries do not support broader conclusions.
12. What the Result Does, and Does Not, Mean
This trial record identifies a randomized comparison of ciclesonide and fluticasone in adults with stable asthma and describes an endpoint intended to measure change in AMP airway responsiveness from baseline. It also makes clear that measurements were considered for small- and large-particle AMP aerosols. Those details establish the question the study was designed to address.
They do not establish the answer. The registry record does not report numerical primary outcome results, a treatment-effect estimate, a confidence interval, or a p-value. Without those results, the direction and size of any observed contrast are unknown from this record. Its completion status and stated design cannot be used as substitutes for the missing outcome analysis.
In general, a statistically estimated difference and its uncertainty help distinguish what the data suggest from what remains uncertain. Even a precise estimate would need interpretation in light of the measurement, study population, treatment schedule, and analysis plan. Here, the primary outcome estimates and analysis plan are not reported, so neither clinical importance nor statistical precision can be evaluated.
The record also does not support conclusions about populations beyond the adults with stable asthma described, or about other doses, schedules, or treatment durations. The listed adverse-event counts are descriptive and should not be taken as a complete comparative safety analysis. The study summary says that safety and tolerability were considered, but the registry entries do not provide detailed event narratives or statistical comparisons.
The most defensible conclusion is therefore about the scope of the evidence available in the registry: the trial question and measurement are described, while the main numerical findings needed to assess the comparison are not reported in the registry record. No claim that one treatment performed better or worse is supported by the listed primary outcome information.
13. Why This Trial Matters Statistically
This trial is statistically notable for defining an endpoint that combines a baseline-to-post-treatment change with distinct AMP particle-size conditions. That creates an important interpretation question: whether the study intended one primary contrast or several related comparisons. The registry indicates that the outcome was not reduced to one comparison, making clear why the analysis plan and condition-specific results would be important for interpretation.
The record also illustrates the difference between a clearly described design and a fully interpretable result. Randomization, masking, parallel groups, treatment regimens, and a timeframe are recorded. Yet those features do not tell readers what the observed group differences were or how uncertain they may be. Numerical estimates and denominators for the primary analyses are necessary to assess the evidence statistically.
The population statement is another key feature. The registry says treatment-effect analyses involved subjects who reached PC20 <640mg/mL. This makes the analysis population relevant to understanding the endpoint, but the record does not report how many participants met the criterion or how many contributed measurements under each condition. That gap limits assessment of precision and of how the analysis population relates to enrollment.
Finally, the entry shows why safety counts and efficacy results should be kept distinct. It reports adverse-event counts, but those counts do not answer the airway-responsiveness question and do not replace comparative safety analyses. In general, readers need outcome estimates, uncertainty, analysis definitions, and participant flow to judge what a trial contributes. The registry record supplies useful design context, but omits the primary numerical findings and several methods details needed for a full statistical evaluation.
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 numerical primary outcome results. It gives the endpoint definition and summary measure but no group means, standard deviations, treatment contrast, confidence interval, or p-value. The primary efficacy question therefore cannot be answered from the recorded results.
The outcome has several categories or time points, including measurements using small and large particles, but the record does not give a result for each condition or identify a prespecified comparison among them. The multiplicity strategy is not reported in the registry record. The statistical analysis plan, including the model and any adjustments, is also not reported.
The stated treatment-effect population is limited to subjects who reached PC20 <640mg/mL, but the record does not give the number meeting that criterion or the number analyzed for each outcome condition. The entry does not describe participant flow, missing measurements, exclusions, or the method used to handle missing data. Enrollment of 37 should not be mistaken for the primary analysis denominator.
Further design details are unavailable, including the randomization sequence, allocation concealment, and identities of the masked parties. A sample-size justification and the study's own statistical plan are not reported in the registry record. The safety information is also limited: the registry lists event counts but does not provide detailed event descriptions, attribution, or comparative uncertainty. These limitations apply to interpretation of the registry entry and do not establish what may appear in other records.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101) — NCT00306163.
- Registry record last updated 2017-02-01; status last verified 2016-09.
- Results first posted 2010-04-26.
- 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
NCT00306163 is a completed Phase 3 randomized, triple-masked, parallel-group study sponsored by AstraZeneca. It enrolled 37 adults with stable asthma and compared ciclesonide 160 µg inhaled once daily with fluticasone 100 µg inhaled twice daily. The study description gives a five-week baseline period and a five-week treatment period.
The primary outcome was mean change from baseline in log PC20 AMP, with measurements described for small and large aerosol particles. Safety and tolerability and Δ (FVC/SVC) at PC20 (AMP) are listed as secondary outcomes. The registry record does not report numerical primary outcome results or a treatment comparison. It states that treatment-effect analyses used subjects who reached PC20 <640mg/mL, without reporting the analysis count.
Safety entries list no serious adverse events as affected in either group, while deaths are not reported as a numerical count. Other adverse-event counts are listed for both groups. The statistical analysis plan, missing-data approach, multiplicity strategy, and sample-size justification are not reported in the registry record.