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 Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR (NCT01880840), a randomized phase 4 study. The primary outcome is Safety.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01880840 |
| Phase | Phase 4 |
| Condition | Allergic Rhinitis |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 191 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Meda Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Children aged at least 6 months and under 6 years with allergic rhinitis were eligible for the study described in the registry record. The record lists 191 participants enrolled. It does not provide a fuller description of eligibility criteria, the enrolled participants’ characteristics, or the numbers of participants in each age stratum.
Intervention
One group received Astepro 0.15% nasal spray, described as 205.5 mcg of azelastine hydrochloride. The listed regimen was 1 spray per nostril twice daily. The study’s objective was to evaluate safety during one month of treatment.
Comparator
The other group received Astepro 0.1% nasal spray, described as 137 mcg of azelastine hydrochloride, also at 1 spray per nostril twice daily. The registry record lists 95 participants in the 0.15% group and 96 in the 0.1% group. It describes the study as randomized and open-label, so parents and children were to know which group they were in.
Primary question
The primary objective was to assess safety using reported adverse experiences, nasal examinations, laboratory evaluations, and vital-sign assessments. The registry lists the primary outcome as safety, measured in adverse events, over one month of treatment. It does not report a formal statistical comparison between doses, nor does it give a prespecified threshold for deciding whether safety differed.
The clinical question is therefore about the safety observations recorded for two doses in a young pediatric population with allergic rhinitis. It is not a question about symptom relief or comparative efficacy: no efficacy outcome is listed among the posted results. The record also says that data for each age stratum would be summarized separately and together, but age-stratum results are not reported in the registry record. The available information should consequently be read as a limited account of safety observations, rather than as a complete evaluation of all safety outcomes or a definitive dose comparison.
3. Trial Design
This was a Phase 4 randomized trial of Astepro 0.15% and Astepro 0.1% nasal sprays in children aged at least 6 months and under 6 years with allergic rhinitis. The registry record lists Meda Pharmaceuticals as the sponsor, a start date of 2013-06, primary completion in 2014-04, and a completed status. Enrollment was 191.
The record describes the allocation as randomized and the masking as none. Its study summary calls the trial open-label and explains that the parent and child would know which group they were in. The two listed groups received the two concentrations at the same stated regimen: 1 spray per nostril twice daily. The intended treatment period for the primary safety outcome was one month. The record does not describe the randomization sequence, how assignments were concealed, or whether any procedures were used to standardize assessment across groups.
There is an important classification detail: the registry record labels the study model as single-group while also listing two randomized dose groups with separate participant counts and outcome values. Those details do not align neatly as a conventional two-group model. The record does not explain the classification, so it is best to report the randomized allocation and the two listed groups without resolving that discrepancy by assumption.
The primary outcome description says safety would be assessed using reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs, with data intended to be summarized separately by age stratum and in combination. The registry lists one outcome measure and no posted analyses. Detailed methods for outcome ascertainment, the analysis population, and the planned statistical comparisons are not reported in the registry record. The record also does not give a sample-size justification or describe interim analyses. Thus, the design information establishes the broad treatment comparison and safety objective, but not the full protocol or statistical analysis plan.
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 | Astepro 0.15% | Astepro 0.1% |
|---|---|---|
| STARTED | 95 | 96 |
| COMPLETED | 87 | 91 |
| NOT COMPLETED | 8 | 5 |
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 | Astepro 0.15% Nasal Spray | Astepro 0.1% Nasal Spray | Total |
|---|---|---|---|---|
| Participants analysed | 95 | 96 | 191 | |
| Age, Categorical: <=18 years | Participants | 95 | 96 | 191 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 3.29 (SD 1.538) | 3.37 (SD 1.595) | 3.33 (SD 1.566) |
| Sex: Female, Male: Female | Participants | 36 | 45 | 81 |
| Sex: Female, Male: Male | Participants | 59 | 51 | 110 |
| Region of Enrollment: United States | participants | 95 | 96 | 191 |
6. Primary Endpoint
The registry lists the primary outcome as Safety, measured over one month of treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | adverse events |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Safety,” with adverse events as its unit and one month of treatment as its timeframe. The stated objective describes a broad safety assessment: reported adverse experiences, nasal examinations, laboratory evaluations, and vital-sign assessments. These measures address different kinds of potential safety observations. Adverse-event reporting captures events that arise or are noted during the study; examinations and laboratory or vital-sign evaluations can identify findings assessed through clinical checks or measurements.
The arm summaries give values of 43 for Astepro 0.15% and 39 for Astepro 0.1%, with 95 and 96 participants, respectively. The registry record labels the outcome as a number and identifies adverse events as the unit. It does not provide further detail specifying whether these values count distinct events, participants with one or more events, or another summary of adverse experiences. That distinction matters because an event count and a count of affected participants answer different questions: one participant may experience more than one event.
The broader safety description also does not specify how nasal examinations, laboratory evaluations, and vital signs were combined with adverse-event reporting in the primary outcome. A single summary value cannot be assumed to represent every component or every kind of safety finding. In general, a safety endpoint is used to describe unwanted events and observations during exposure, rather than to establish symptom benefit. The registry record does not report a prespecified statistical definition of a clinically important difference or a formal inferential comparison for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome values are 43 adverse events in the Astepro 0.15% group and 39 in the Astepro 0.1% group. The corresponding group sizes are 95 and 96. These are descriptive figures. The registry record does not report an estimated between-group effect, confidence interval, p-value, or analysis adjusting for other variables. It therefore does not establish how precisely the observed counts distinguish the two dose groups.
The meaning of the counts is also limited by the outcome description. Although the unit is adverse events and the parameter is a number, the record does not explain whether the values represent distinct events or participants affected. They should not be restated as the number of children who experienced an adverse event unless the outcome definition confirms that interpretation. Nor should they be treated as rates: the record does not provide a rate calculation or exposure-adjusted analysis.
The serious adverse-event information is separately reported. The record lists a serious-event count of 1 among 95 at risk in the 0.15% group and 0 among 96 at risk in the 0.1% group. It identifies exacerbation of asthma as the top serious-event term and gives 1.1%. These observations describe what was recorded; they do not, by themselves, show that dose caused the event or that the groups differ reliably. The record’s deaths field is not populated, so death counts are not reported in the registry record.
Other adverse-event figures are also listed: 23 affected among 95 at risk in the 0.15% group and 15 affected among 96 at risk in the 0.1% group. These are distinct from the serious-event figures. The registry record does not supply a full list of non-serious event terms or a comparative analysis of these counts. No conclusion about the relative safety of the doses can be drawn solely from the raw counts, especially when the outcome definition and event-level details are incomplete.
Randomization can support a fair comparison when allocation and follow-up are implemented as intended, but it does not eliminate uncertainty in a study’s observed results. Open-label knowledge of assignment can also affect reporting or assessment, depending on how outcomes are collected. The record does not describe procedures that would clarify these issues. Because no inferential analysis is posted, the numerical differences in the descriptive counts should not be interpreted as evidence of a statistically established difference or equivalence.
The registry record reports no secondary posted outcomes and no analyses. It does not report age-stratum results, despite stating that those summaries were intended. The available evidence is therefore a narrow descriptive snapshot of safety observations over one month, not a complete account of all planned summaries. Any interpretation should retain that distinction between observations and evidence from a prespecified comparative analysis.
9. Statistical Methods Explained
Statistical methods determine how observations are summarized and how uncertainty in a comparison is assessed. For this trial, the registry record gives descriptive arm values and participant counts, but lists no analyses. The statistical plan, including any planned tests, models, covariate adjustments, or decision rules, is not reported in the registry record. The explanations below describe general statistical concepts relevant to reading a randomized safety comparison; they do not assert that those methods were used in this trial.
What do the arm counts describe?
A count is a straightforward summary of how many events or affected individuals were recorded, but its interpretation depends on the unit. An event count can include repeated events in one person, whereas a count of participants with at least one event counts each affected person once. Those measures can differ even when they come from the same study. Here, the outcome is described as a number of adverse events, but the registry record does not give enough detail to determine precisely which counting convention produced the primary values. The separate adverse-event information uses affected counts, but it does not clarify the definition of the primary measure.
Counts are also influenced by the number of people observed and the length and completeness of follow-up. The group sizes and one-month treatment timeframe are reported, but details about follow-up after treatment, missed visits, and exposure time are not. A rate can account for differing observation time when it is calculated with an appropriate denominator, but no such rate is reported. It would not be appropriate to create one from the listed summaries.
Why does a comparison need uncertainty estimates?
A difference between two observed summaries can arise from a true difference, random variation, or features of measurement and follow-up. A confidence interval is a general statistical tool that expresses a range of values compatible with the data under a specified method and assumptions. Its width conveys precision: narrower intervals indicate greater precision, while wider intervals indicate less. A confidence interval does not guarantee that the true value lies within the interval, and its interpretation depends on the analysis model and study design.
No confidence interval or other uncertainty estimate is reported for the primary outcome. No p-value or formal test is reported either. Consequently, the posted counts do not quantify the uncertainty around a dose comparison. A lack of a reported statistically significant result cannot be inferred, because no test result is posted; equally, the counts alone cannot establish that the doses are equivalent or meaningfully different.
How does randomization relate to the analysis?
In general, random allocation aims to make treatment groups comparable at the time of assignment with respect to measured and unmeasured characteristics. This supports causal comparisons when the allocation process is properly implemented and when later events such as loss to follow-up, non-adherence, and outcome assessment are handled appropriately. Randomization does not guarantee identical groups in a particular trial, and it does not remove the need to report how participants were analyzed.
The registry record says allocation was randomized, but does not describe the sequence-generation method or concealment procedures. It also describes the study as open-label. In general, awareness of group assignment may influence reporting, decisions to seek care, or assessments that involve judgment. Some outcomes, such as laboratory measurements, may be less dependent on subjective judgment, but the record does not provide enough information to evaluate the assessment procedures used. No claim about actual bias can be made from the open-label designation alone.
What does over-dispersion mean for event counts?
General count-data methods sometimes assume that variability follows a particular relationship to the average count. Over-dispersion occurs when the observed variability is greater than that assumption allows. It can arise, for example, when some participants experience many events while others experience few, or when event risk differs across people. If a model ignores over-dispersion, its uncertainty estimates may be too small. This is a general consideration for repeated or clustered event counts, not a finding reported for this study. The registry record gives no event-level data or statistical model with which to assess over-dispersion.
What can sample-size planning show?
A sample-size calculation is a planning exercise that asks how many participants might be needed to detect an effect under stated assumptions about the effect, variability, significance level, allocation, and analysis. A planning illustration based on an observed effect is different from a trial’s original design justification. It is also different from observed power, which should not be used as a retrospective substitute for an uncertainty interval. Any displayed planning illustrations should therefore be read as conditional estimates, not as evidence that the trial had a particular probability of finding a result or that it was adequately designed for a specific effect.
The registry record does not report the trial’s own sample-size justification, target effect, or planned power. It also does not provide enough inferential results to assess precision from the primary outcome. The planning assumptions described for any illustration are not evidence of the choices made by the sponsor when designing the trial.
Why might a count comparison need a model?
For a general comparison of event counts, an analyst might consider whether the endpoint is an event total, a count of people affected, or a rate over time. The choice matters: repeated events may call for methods that account for within-person clustering, while a binary outcome of any event versus none has a different structure. Adjustment for follow-up time may be relevant when exposure differs. These approaches require definitions and data that are not reported in the registry record. No particular model can be attributed to this trial.
In short, the posted arm counts allow a descriptive reading but not a reconstruction of the statistical analysis. The record does not report the full endpoint definition, analysis population, missing-data approach, model, uncertainty estimates, or multiplicity strategy. General statistical principles can explain what such methods would address, but cannot fill those reporting gaps or turn the descriptive values into an inferential conclusion.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several outcomes, groups, timepoints, or statistical comparisons are examined. The more questions tested, the greater the chance that at least one result may appear notable by chance if no adjustment or interpretation plan is used. General approaches include prespecifying a primary comparison, controlling an overall error rate, or treating additional analyses as exploratory. The registry record lists one primary outcome measure and no secondary posted outcomes, but the number of analyses is listed as zero. A detailed plan for handling multiple endpoints or comparisons is not reported in the registry record.
The record says that age-stratum data were intended to be summarized separately and combined. It does not post those results, explain the strata, or describe whether subgroup comparisons were planned as inferential analyses. Therefore, no conclusion about consistency across ages can be drawn. The record also does not describe whether multiple adverse-event terms were examined or how they were selected for reporting.
Missing-data handling is another important part of a statistical plan. Participants may have incomplete outcome assessments or may stop treatment before the planned follow-up ends. In general, analysts need to explain how such observations were handled and whether analyses included all randomized participants, only those treated, or another defined population. The registry record does not report an analysis population, missing-data counts, reasons for missingness, or a method for handling missing outcomes. The enrollment and group counts alone do not establish how many participants contributed to each particular safety assessment.
These absences limit interpretation without demonstrating that the trial had a specific methodological flaw. They mean that the posted record does not show how multiplicity, incomplete follow-up, or analysis-set choices were addressed. The observed figures should be understood as the reported summaries, not as a complete account of all participants or all planned statistical work.
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 |
|---|---|---|---|
| Astepro 0.15% Nasal Spray | 1 | 95 | 1.1% |
| Astepro 0.1% Nasal Spray | 0 | 96 | 0.0% |
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 |
|---|---|
| Astepro 0.15% Nasal Spray | 23 of 95 |
| Astepro 0.1% Nasal Spray | 15 of 96 |
Most frequent serious adverse event terms
| Event term | Organ system | Astepro 0.15% Nasal Spray | Astepro 0.1% Nasal Spray |
|---|---|---|---|
| exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | 1 of 95 | 0 of 96 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Astepro 0.15% Nasal Spray | Astepro 0.1% Nasal Spray |
|---|---|---|---|
| pyrexia | General disorders | 6 of 95 | 5 of 96 |
| cough | Respiratory, thoracic and mediastinal disorders | 3 of 95 | 1 of 96 |
| epistaxis | Respiratory, thoracic and mediastinal disorders | 3 of 95 | 0 of 96 |
| sneezing | Respiratory, thoracic and mediastinal disorders | 3 of 95 | 0 of 96 |
| upper respiratory tract infection | Infections and infestations | 2 of 95 | 1 of 96 |
| vomiting | Gastrointestinal disorders | 2 of 95 | 1 of 96 |
| otitis media | Ear and labyrinth disorders | 0 of 95 | 3 of 96 |
| dysgusia | Gastrointestinal disorders | 2 of 95 | 0 of 96 |
| rhinalgia | Respiratory, thoracic and mediastinal disorders | 2 of 95 | 0 of 96 |
| dermatitis,contact | Skin and subcutaneous tissue disorders | 0 of 95 | 2 of 96 |
Serious events with the highest arm-level rate: exacerbation of asthma (1.1%).
The serious adverse-event information lists 1 serious event among 95 at risk in the Astepro 0.15% group and 0 among 96 at risk in the Astepro 0.1% group. Exacerbation of asthma is the listed top serious-event term, reported as 1.1%. These figures describe the registry entries; they do not establish that the treatment caused the event or that serious-event risk differed between doses.
Small counts are inherently difficult to interpret as evidence about comparative risk. A zero count in a group means no serious event was recorded in that group in the posted summary; it does not prove that the underlying risk is zero. Likewise, a count of 1 does not, by itself, indicate a stable estimate of the frequency of such events. The record does not provide confidence intervals, a statistical test, or additional detail about timing, outcome, or relatedness of the serious event.
The deaths field is not populated. Death counts are therefore not reported in the registry record; they should not be described as zero. Serious events are also not interchangeable with all adverse events. The record separately lists other adverse-event affected counts, but those should not be combined with the serious-event figures or interpreted as a complete event profile.
12. What the Result Does, and Does Not, Mean
The trial record offers descriptive safety information for children with allergic rhinitis who received one of two Astepro nasal-spray concentrations for a stated treatment period of one month. It reports the primary outcome as adverse-event counts of 43 and 39 in the respective groups, alongside group sizes of 95 and 96. It also reports serious-event counts and other adverse-event affected counts. These summaries indicate what the registry record contains, but their scope and interpretation are limited by the absence of a detailed outcome definition and comparative analysis.
The results do not establish that one dose is safer than the other. There is no reported effect estimate with an uncertainty interval, no p-value, and no statistical analysis in the registry record. A numerical difference between descriptive counts is not, on its own, evidence of a reliable treatment difference. Nor does the absence of a reported comparison demonstrate that the doses are equivalent. Equivalence or non-inferiority requires a prespecified question and appropriate analysis, neither of which is reported.
The findings also do not establish efficacy. The stated purpose concerns safety, and no efficacy outcome is posted. They do not describe safety beyond the trial’s one-month treatment timeframe, nor do they answer questions about outcomes in age strata because those results are not posted. The record does not provide detailed baseline characteristics, follow-up completeness, or a complete account of adverse-event terms.
Open-label design is relevant context, but it is not enough by itself to determine whether observations were biased. Awareness of assignment can affect reporting or assessment in general, while the actual impact depends on study procedures that are not described in the registry record. Randomized allocation is also relevant context, but it does not substitute for information on how assignments were generated, how outcomes were defined, or how the analysis was conducted.
The appropriate statistical reading is therefore restrained: the registry records safety observations in two randomized dose groups, but does not provide the inferential evidence needed for a precise comparative conclusion. The figures should be treated as descriptive results and interpreted alongside the substantial reporting gaps, not as a stand-alone determination about safety.
13. Why This Trial Matters Statistically
This trial illustrates why statistical interpretation depends on more than a pair of arm counts. The record identifies a pediatric population, two randomized dose groups, an open-label design, a one-month safety timeframe, and several types of safety assessment. Those details define the broad question. However, the reported primary values do not fully explain what was counted, and there is no posted comparative analysis or estimate of uncertainty. Statistical readers need both a clear endpoint definition and an analysis that matches that definition.
Safety outcomes can be especially challenging because one person may experience multiple events, event types can differ in seriousness, and observation time may not be identical for everyone. A total count, a count of affected participants, and a time-adjusted rate are different summaries. Treating them as interchangeable can lead to misleading conclusions. The distinct serious-event and other-event entries in this record underline the value of keeping endpoint definitions and categories explicit.
The record also highlights the importance of reporting planned analyses and analysis populations. Without those details, readers cannot tell how missing assessments, age-stratum summaries, or multiple event terms were handled. Nor can they assess how precise the comparison is. A randomized design is valuable, but readers still need transparent reporting of follow-up, outcomes, and uncertainty to evaluate what the data support.
Finally, the mismatch between the single-group model label and the two randomized groups is a reminder that registry classifications may not fully describe the design. The underlying study should be interpreted from the details that are actually recorded, without silently resolving unexplained inconsistencies. Careful statistical reading distinguishes documented details from assumptions and descriptive observations from inferential conclusions.
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 registry record provides limited detail about the trial’s methods and results. It lists one primary outcome and no posted analyses, but does not give a full statistical analysis plan, sample-size justification, interim-analysis plan, or specific inferential method. The interpretation of the primary values is constrained because the record identifies the measure as a number of adverse events without clarifying whether the values count events or participants affected.
Although the record says that data were to be summarized by age stratum and combined, age-stratum results are not reported. The record does not describe the age strata or provide participant characteristics that would help readers understand the enrolled population. It also does not report follow-up completeness, missing-data counts, reasons for discontinuation, or the analysis population used for each outcome. These omissions prevent a full assessment of how representative the posted summaries are of all enrolled participants.
The open-label design means that parents and children knew group assignment, according to the study summary. The record does not describe blinding of outcome assessors or procedures for collecting and classifying adverse experiences. These details matter when interpreting outcomes that may involve reporting or judgment. The registry record also does not provide a full list of non-serious adverse-event terms, event timing, or details about whether serious events were considered related to treatment.
There is a design-classification ambiguity: the record labels the model as single-group while also listing two randomized dose groups. No explanation is reported. The serious-event death field is not populated, so it cannot be read as a confirmed zero. Finally, the one-month treatment timeframe limits the stated safety observation period; longer-term outcomes are not reported in the registry record. These limitations are reporting constraints and should not be mistaken for proof that particular procedures were absent from the underlying study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR — NCT01880840.
- Registry record last updated 2015-06-29; status last verified 2014-04.
- Results first posted 2015-06-29.
- 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.
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18. Record Summary
NCT01880840 is a completed Phase 4 randomized, open-label study sponsored by Meda Pharmaceuticals. It enrolled 191 children aged at least 6 months and under 6 years with allergic rhinitis. The two listed groups received Astepro 0.15% or Astepro 0.1% nasal spray, each described as 1 spray per nostril twice daily. The primary safety timeframe was one month of treatment.
The registry reports primary adverse-event values of 43 and 39, with group sizes of 95 and 96. It separately lists serious-event counts of 1 and 0, other adverse-event affected counts of 23 and 15, and exacerbation of asthma as the top serious-event term at 1.1%. The record does not report a comparative analysis, uncertainty estimates, or age-stratum results. Its model label is single-group despite the two randomized groups, and it does not explain this classification.