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 The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation (NCT02877485), a randomized phase 4 study. The primary outcome is Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02877485 |
| Phase | Phase 4 |
| Condition | Nasal Obstruction |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Quadruple |
| Enrollment | 42 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Stanford University |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes patients with nasal obstruction and nasal septal deviation. Its primary-outcome description refers to patients requiring nasal surgery for nasal breathing complaints, nasal cosmesis, or both. The record does not report further eligibility details or the characteristics of the enrolled group, so the extent to which the participants represent other people with nasal obstruction cannot be assessed from this information.
Intervention
The active treatment was intranasal triamcinolone acetonide. In the sequence beginning with active treatment, participants received 6 weeks of therapy before switching to placebo. In the other sequence, active treatment followed the placebo period.
Comparator
The comparator was Ayr saline nasal mist, described in the registry as placebo. Each treatment period lasted 6 weeks, with a 2 week washout between periods. The record does not report additional details about how treatment use or adherence was assessed.
Primary question
The trial asked whether nasal obstruction, measured with the Nasal Obstruction Symptom Evaluation (NOSE) score, differed following triamcinolone treatment and placebo. The registry lists pre-spray and post-spray scores around the treatment periods, but does not report the resulting scores, a treatment contrast, or its uncertainty. The clinical question is therefore clear from the design, while the posted record does not establish the direction or size of the observed difference.
3. Trial Design
This was a Phase 4, randomized, quadruple-masked crossover trial sponsored by Stanford University. The registry lists enrollment of 42 and a completed status. The recorded start was 2016-08, and primary completion was 2019-08-15. These details describe the registered study; they do not supply outcome results or explain how the completed trial was conducted in practice.
Participants were assigned to treatment sequences rather than to parallel groups that remained on a single treatment. One sequence began with triamcinolone acetonide for 6 weeks, followed by Ayr spray for 6 weeks, with a 2 week washout between treatment periods. The other began with Ayr spray and then switched to triamcinolone, with the same stated treatment-period and washout durations. This structure allows outcomes under both treatments to be collected within the crossover design, but the registry record does not describe the statistical method used to account for that structure.
Quadruple masking is the registry’s classification of the masking arrangement. The record does not identify the masked roles or describe how masking was maintained. It also does not report details of the randomization procedure, allocation concealment, adherence, deviations from assigned sequence, or the handling of participants who did not complete both periods. Those details are not reported in the registry record.
The registry lists a primary NOSE outcome and a secondary NOSE outcome following surgery in a subset of patients who elect to undergo surgery. It reports that the trial is completed, but completion status alone does not indicate whether every planned analysis is available or whether the posted information includes the final 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.
Overall Study
| Stage | Triamcinolone Acetonide Then Ayr Spray | Ayr Spray Then Triamcinolone Acetonide |
|---|---|---|
| STARTED | 22 | 20 |
| COMPLETED | 22 | 20 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Patients requiring nasal surgery for nasal breathing complaints, nasal cosmesis or both.
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 | Triamcinolone Acetonide Then Ayr Spray | Ayr Spray Then Triamcinolone Acetonide | Total |
|---|---|---|---|---|
| Participants analysed | 22 | 20 | 42 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 21 | 20 | 41 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Age, Continuous | years | 32.5 (SD 10.1) | 33.7 (SD 14.4) | 33.0 (SD 12.2) |
| Sex: Female, Male: Female | Participants | 11 | 5 | 16 |
| Sex: Female, Male: Male | Participants | 11 | 15 | 26 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 22 | 20 | 42 |
6. Primary Endpoint
The registry lists the primary outcome as Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray), measured over Pre-spray NOSE score - 6 weeks Post spray NOSE score- 2 weeks washout - Pre spray Pre-spray NOSE score - 6 weeks Post spray NOSE score.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is nasal obstruction measured using the Nasal Obstruction Symptom Evaluation (NOSE) score following treatment with triamcinolone acetonide and placebo. The registry describes a mean score and standard deviation and lists assessments before and after the spray periods, with a washout between treatments. Its timeframe wording refers to pre-spray and 6 weeks post-spray scores in both treatment periods.
The NOSE instrument is a quality-of-life questionnaire developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It has 5 items, each scored on a 5-point Likert scale from 0 to 4. The raw score ranges from 0-20 and is scaled to 0-100 by multiplying by 5. A score of 0 represents no problem, while 100 represents the worst problem. The scale gives a structured way to quantify symptoms that might otherwise be described in less standardized terms.
The registry record does not report the observed scores, standard deviations, change estimates, or comparison between treatments. It also does not state a threshold for interpreting a difference as clinically important. The endpoint definition explains what was intended to be measured, but does not by itself show what the trial found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized crossover comparison of intranasal triamcinolone acetonide with Ayr saline spray and names the NOSE score as the primary outcome. It does not report the primary outcome values or a treatment-effect estimate. Consequently, the direction, magnitude, and precision of any observed difference cannot be described from the registry information available for this analysis.
The outcome is defined as a mean on the NOSE scale, with standard deviation as the stated measure of dispersion. A mean would describe the average score in the relevant observations; a standard deviation would describe how spread out those scores are around that average. Neither is reported for the treatment periods. There is also no reported confidence interval, p-value, or other inferential result for the primary comparison. Without those results, it is not possible to assess how compatible the data are with a range of treatment effects or how precisely an effect was estimated.
The registry includes the planned sequence of treatment periods and a washout. In a crossover study, observations under different treatments can be related because they come from people participating in both periods. General statistical interpretation therefore depends on the method used to address within-person correlation and possible period or sequence effects. The registry record does not report those methods or their results. The design description alone cannot establish whether these issues affected the estimate.
The record lists enrollment of 42, but that enrollment figure is not an outcome result and does not establish how many observations contributed to each analysis. Group-specific adverse-event at-risk figures are listed separately, and they should not be treated as the number of observations used in the primary endpoint analysis. The analysis population and the number of participants with evaluable NOSE scores are not reported in the registry record.
The registry reports a secondary NOSE outcome following surgery in a subset of patients who elect to undergo surgery. No result for that outcome is reported. Because the subset is described by a choice to undergo surgery, it is distinct from the full population described for the primary question; the record does not provide details allowing the secondary result or its relationship to the primary outcome to be evaluated.
The appropriate conclusion from the posted registry information is limited: the study was completed and its primary outcome was defined, but the primary comparison’s numerical results are not reported in the registry record. No claim about the treatment’s effect or the absence of an effect can be drawn from a missing estimate. The clinical interpretation would require the outcome results and enough information about the analysis to understand how they were obtained.
9. Statistical Methods Explained
The registered study is randomized and uses a crossover model. General statistical concepts help explain what those design features imply, but the registry record does not report the primary analysis method, the fitted model, or the inferential results. The distinctions below are therefore general explanations, not a description of an analysis confirmed to have been used in this trial.
Why does a crossover design affect analysis?
In a crossover study, participants receive treatments in sequence, so outcomes from different periods may be related within the same person. General analyses of crossover data can account for this relationship rather than treating every period’s score as if it came from an unrelated participant. Accounting for within-person correlation can affect the estimated uncertainty. The registry identifies the model as crossover but does not state whether the analysis used paired comparisons, a repeated-measures model, or another method.
Period effects are also a general consideration: outcomes may differ between earlier and later periods for reasons apart from the assigned treatment. Sequence effects can matter if the order of treatment is associated with outcomes. A washout period appears in both registered sequences. In general, washout periods separate treatment periods, but their presence alone does not show whether residual effects were absent or whether the washout was sufficient. The registry record does not report tests or adjustments for period, sequence, or carryover effects.
What do the mean and standard deviation describe?
The primary outcome specifies a mean and standard deviation for a continuous score. In general, the mean gives a measure of the central value, while the standard deviation describes variability among the measured scores. These summaries describe different features of the data: a similar mean can occur alongside different degrees of variation. The registry does not report the treatment-period means or standard deviations, so these features cannot be assessed for this trial.
A comparison of means would need to reflect the trial’s crossover structure and the precise outcome definition. For example, an analysis might compare scores after each treatment while accounting for the repeated observations, or compare changes from pre-treatment scores. Those are general analytical possibilities, not methods documented for this trial. The registry’s timeframe lists pre-spray and post-spray measurements, but does not clarify the exact contrast used for the primary analysis.
What does a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated effect by giving a range of values compatible with the data and the analysis assumptions. Its width reflects precision: a narrower interval indicates greater precision than a wider interval, all else being equal. A confidence interval is not reported for the primary comparison in the registry record. No numerical statement about the precision of the treatment contrast can therefore be made.
A p-value, when reported, addresses how unusual data at least as incompatible with a specified null hypothesis would be under the statistical model. It does not measure the size or clinical importance of an effect, and it does not establish that the null hypothesis is true or false. The registry record does not report a primary-outcome p-value. Its absence means the posted record cannot support a significance-based interpretation.
Why can over-dispersion matter?
Over-dispersion is a general issue for outcomes whose variability exceeds what a chosen statistical model expects. It is most often discussed with count or binary data, rather than a continuous score such as the NOSE measure. If a model underestimates variability, standard errors can be too small and intervals too narrow; methods that allow for extra variability may be more appropriate in settings where over-dispersion is present. This is general statistical context, not a reported feature of the primary NOSE outcome. The registry does not report a model assessment that would indicate whether over-dispersion was considered for any analysis.
What do the planning assumptions mean?
The registry describes assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and effects defined as fractions of an observed effect. Those illustrations are not the trial’s design justification, and the record does not report a sample-size justification for the trial itself. A planning calculation is not observed power and cannot substitute for an effect estimate or confidence interval. No numerical planning results are reported in the registry information.
General sample-size planning asks how much information might be needed to detect an effect under specified assumptions. It depends on the effect chosen, the variability of the outcome, the analysis, and the desired error rates. When assumptions are based on an observed effect, the result is an illustration tied to that assumed effect, not evidence that the trial achieved a particular level of power. The registry record does not report the effect estimate or variability needed to examine such an illustration independently.
In short, the registered design identifies the broad comparison and repeated measurement structure, while the registry record does not document the statistical procedures or numerical results needed to evaluate the analysis. General explanations of means, uncertainty, repeated measurements, and planning should not be mistaken for trial-specific findings.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes multiple score time points across treatment periods. The registry’s recorded note indicates that the primary outcome has several categories or time points and was not reduced to a single comparison. The record does not report which contrast, if any, was designated as the primary numerical test, or whether comparisons across time points were adjusted for multiplicity.
Multiplicity is a general concern when several outcomes, time points, or comparisons are examined. The more comparisons made, the greater the chance that an apparently notable result could occur by chance if each is interpreted separately. Statistical approaches can define a hierarchy of outcomes or adjust inference across comparisons. The registry record does not describe such an approach, so it is not possible to determine how multiplicity was handled.
The record lists a secondary NOSE outcome following surgery in a subset who elect to undergo surgery. It also lists 2 outcome measures and 2 analyses. However, details of the analysis populations, prespecified hypotheses, and any multiplicity strategy are not reported in the registry record.
Missing-data handling is also not reported in the registry record. The available information does not say how missing scores, incomplete treatment periods, withdrawals, or protocol deviations were handled. It does not identify whether the analysis used all randomized participants, only participants with complete observations, or another population. Those are important distinctions in a crossover study because the primary comparison may depend on measurements from both periods.
Without the outcome-level analysis details, the registry information does not allow assessment of the influence of missing observations, the analysis population, or multiplicity on the reported inference. No assumption about the direction or size of any such influence can be made.
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 |
|---|---|---|---|
| Triamcinolone Acetonide | 0 | 22 | 0.0% |
| Ayr Spray | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Triamcinolone Acetonide | 0 of 22 |
| Ayr Spray | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Triamcinolone Acetonide | 0 of 22 |
| Ayr Spray | 0 of 20 |
The registry lists serious adverse events for the triamcinolone acetonide group as 0 among 22 at risk, and for the Ayr spray group as 0 among 20 at risk. It also lists other, non-serious adverse events as 0 among 22 at risk for triamcinolone and 0 among 20 at risk for Ayr spray. Deaths are listed as 0 in both groups, and no top serious-event terms are listed.
These figures describe what was recorded in the registry for the listed groups. They do not establish that no adverse events could occur, and they do not describe the possible frequency of events beyond the recorded observation. A zero count is not a guarantee of zero risk. The registry does not provide event definitions, follow-up details for safety, or an explanation of how the at-risk denominators relate to participation across the crossover periods.
The group figures should be read as reported, not combined into a new total or interpreted as the number of unique participants in the crossover trial. The record also does not report a comparative safety analysis, uncertainty intervals, or tests comparing adverse-event counts. These registry entries are descriptive and do not establish a treatment effect on safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, quadruple-masked crossover trial was completed to compare triamcinolone acetonide with Ayr saline spray for nasal obstruction, using the NOSE score as the primary outcome. It gives the treatment sequence descriptions and identifies the intended score measurement. It does not report the primary outcome results.
That distinction matters. A study’s design and its result are different kinds of information. The design describes how a comparison was planned; the result requires observed scores and an analysis of those scores. Because no treatment means, contrast, confidence interval, or primary-outcome p-value is reported, the record does not show whether scores were higher or lower after either treatment, how large any difference was, or how precisely it was estimated.
The absence of a reported result should not be interpreted as evidence that the treatments produced the same outcome. Nor does the registry record support a conclusion that either treatment changed nasal obstruction. A conclusion in either direction would require numerical outcome results and an account of the analysis.
The listed adverse-event figures report no serious or other adverse events in the stated at-risk groups, but they do not establish that the chance of an event is zero. The safety entries do not replace the missing efficacy outcome results, and they are not a comparative analysis.
The registry does provide useful context for interpreting any fuller report: the outcome was a scaled symptom score, treatment was delivered in crossover sequences, and a washout separated the periods. A complete interpretation would also need the observed scores, the treatment-effect estimate and its uncertainty, the analysis population, and the method used to account for repeated measurements and the treatment sequence. Those details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because its crossover structure makes the relationship between repeated observations important. The treatment sequences expose participants to both triamcinolone acetonide and Ayr spray, with a washout between periods. In general, crossover studies can make within-person comparisons informative, but valid interpretation depends on suitable analysis of repeated measurements and consideration of period and sequence effects. The registry record does not report how those features were handled.
The choice of a symptom score also illustrates the difference between a defined endpoint and an interpretable result. The NOSE instrument turns responses about nasal obstruction into a scaled score, with lower values representing fewer problems and higher values representing worse problems. The registry names the outcome and its summary measures, but does not give the score distributions or treatment contrast. Without those data, the measure’s clinical and statistical findings cannot be evaluated.
The record further distinguishes the primary outcome from a secondary score following surgery in a subset who elects surgery. Such outcome definitions require clarity about the population and the question each analysis addresses. The registry does not report the results or the analysis populations for these outcomes.
Finally, a completed status does not ensure that numerical results are included in the registry entry. This record demonstrates why design information, safety counts, outcome definitions, and inferential results must be read as separate evidence. The trial’s registered question can be described, but its primary statistical result cannot be reconstructed from the information reported.
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 central limitation for interpreting this trial from the registry record is that the primary NOSE outcome results are not reported. The record gives no treatment-period means, standard deviations, contrast estimate, confidence interval, or p-value. Consequently, the magnitude, direction, and precision of the primary comparison remain unknown.
The timeframe wording identifies pre-spray and 6 weeks post-spray scores around treatment periods, but it does not specify the exact contrast used in the analysis. The registered outcome description also includes multiple time points, and the registry note says the primary outcome was not reduced to a single comparison. The intended inferential target is therefore not fully clear from the posted information.
The record identifies a crossover model and includes a 2 week washout, but does not report the statistical model or how within-person correlation, period effects, sequence effects, or possible carryover were assessed. It also does not describe randomization procedures, adherence, protocol deviations, or the analysis population. These omissions prevent assessment of whether the analysis matched the design and how incomplete observations were handled.
The secondary outcome concerns a subset of patients who elect to undergo surgery, but its results and analysis details are not reported. The registry also does not provide broader participant characteristics or a sample-size justification. Planning assumptions listed for illustrations should not be treated as the trial’s own design rationale or as observed power.
The adverse-event entries are limited to the recorded counts and at-risk figures. The registry does not provide event definitions or enough detail to interpret follow-up and ascertainment. These limitations do not show that the study’s underlying results were absent; they mean that the registry record does not report the information needed for a fuller statistical assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation — NCT02877485.
- Registry record last updated 2020-08-13; status last verified 2020-08.
- Results first posted 2020-08-13.
- 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
The registry describes a completed, randomized, quadruple-masked Phase 4 crossover trial sponsored by Stanford University, with enrollment of 42. It compared triamcinolone acetonide with Ayr saline spray in treatment sequences that each included 6 week periods and a 2 week washout.
The primary outcome was the NOSE score, a scaled measure of nasal obstruction symptoms. A secondary outcome concerned NOSE scores following surgery in a subset who elect to undergo surgery. The registry lists no serious or other adverse events in the stated at-risk groups.
Although the study status is completed, the registry record does not report the primary outcome values, treatment comparison, or statistical uncertainty. It also does not report the main analysis method, missing-data approach, or multiplicity handling. The posted information therefore describes the trial question and design but does not establish the primary outcome result.