Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen (NCT00791973), a randomized phase 4 study. The primary outcome is Change in Tryptase Level From Baseline to Post-antigen Challenge.

2. Clinical Question

The study focused on an early reaction to nasal allergen challenge, with tryptase measured in nasal lavages. Its primary endpoint was the change in tryptase level from baseline to after challenge, after one week of treatment. A secondary outcome concerned total eye symptom scores after antigen challenge, reflecting the study's interest in how nasal and eye symptoms relate in people with allergies.

The registry describes the trial as randomized and crossover. In a crossover design, each participant receives both treatments in sequence, so the comparison can use within-person information rather than treating the treatment groups as wholly separate sets of people. The recorded treatment sequences were Veramyst followed by placebo, or placebo followed by Veramyst, with the washout period between them.

The posted primary summaries are medians for the two treatment conditions, and the registry reports a Wilcoxon signed-rank test. The result therefore addresses the recorded tryptase endpoint; it does not, by itself, answer whether eye symptoms changed or whether nasal and eye symptoms are related. Those questions require results for the secondary outcome and any analysis of the relationship, neither of which is described by the primary result.

3. Trial Design

This completed Phase 4 study was randomized, triple-masked and used a crossover model. Enrollment was 15. The treatment sequences were Veramyst followed by placebo, or placebo followed by Veramyst. Each treatment was given once daily for one week, and a one-week washout period separated the treatment periods. The registry does not report who was masked, how the sequence was generated, or how treatment adherence was assessed.

The crossover arrangement matters for interpreting the comparison. Each participant was intended to experience both treatment conditions, allowing a paired comparison that accounts for stable differences between people. However, the registry record does not describe how the analysis handled treatment sequence, period effects, carryover, or incomplete participation in either period. A washout is part of the stated schedule, but its intended rationale and any assessment of residual treatment effects are not reported in the registry record.

The primary endpoint was change in tryptase from baseline to post-antigen challenge, measured after one week of treatment. The reported treatment summaries list 15 participants for Veramyst and 15 for placebo. In a crossover trial these counts refer to treatment conditions, not necessarily to 30 different participants. The registry does not state whether every participant contributed usable measurements in both periods or how any missing measurements were handled.

The study began in 2008-11, had primary completion in 2009-04, and is recorded as completed. The sponsor was the University of Chicago. The record identifies allergic rhinitis as the condition and includes one secondary outcome, total eye symptom scores after antigen challenge. Further details about eligibility, the challenge procedure, allocation concealment, protocol deviations, and the statistical analysis plan 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.

Before assignment: 15 of the 24 subjects screened were eligible for the study and were randomly assigned to groups

First Intervention (1 Week)

Washout (1 Week)

Second Intervention (1 Week)

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Tryptase Level From Baseline to Post-antigen Challenge, measured over After one week of treatment wtih veramyst or placebo.

The primary endpoint is the change in tryptase level from baseline to after nasal antigen challenge. Tryptase was measured in nasal lavages and reported in mcg/L. The stated timeframe is after one week of treatment with Veramyst or placebo. Tryptase is the laboratory measure chosen for this endpoint; the registry does not provide a fuller rationale for selecting it or describe the specific timing of lavage collection relative to challenge.

Change from baseline is used to describe how a measurement differs from its starting value over the stated treatment and challenge period. Comparing that change between the two treatment conditions is intended to distinguish the observed response during one condition from the response during the other. In a crossover study, the within-person comparison can be informative because the same participant experiences both conditions. The exact formula used to calculate change, including the subtraction order, is not reported in the registry record, so the direction represented by a higher change value cannot be established from the record alone.

The registry identifies the summaries as medians with inter-quartile range dispersion. It records a median of 0.0 for Veramyst, with bounds of 0.0 to 11.8, and a median of 2.31 for placebo, with bounds of 0.0 to 8.8. Those bounds describe the reported spread, not a confidence interval for the treatment contrast. The record does not include a confidence interval for the difference between treatment conditions, which limits how precisely the contrast can be judged.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General explanation: what the summaries represent. A median is the middle value when observations are ordered. It is a measure of the center that is less influenced by extreme observations than the arithmetic mean. The registry labels the dispersion as an inter-quartile range, which describes the middle portion of the observed distribution. For Veramyst, the recorded median is 0.0 and the bounds are 0.0 to 11.8. For placebo, the median is 2.31 and the bounds are 0.0 to 8.8. These summaries describe the treatment-condition measurements; they do not directly give the paired difference for each participant.

General explanation: why a signed-rank test may be used. The Wilcoxon signed-rank test is a nonparametric method commonly used for paired observations. It works with within-pair differences, ranks their magnitudes, and considers their signs. A paired approach fits the general structure of a crossover study because participants receive both treatment conditions. It does not require treating the two conditions as independent samples. The registry names this test, but does not report the paired values, the exact test statistic, the handling of ties or zero differences, or additional details needed to reproduce the analysis.

General explanation: what a p-value says. A p-value describes how compatible the observed test result is with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it is not a measure of the size or clinical importance of an effect. The recorded p-value is 0.33. The registry does not provide a confidence interval for the treatment contrast or state the decision threshold for the primary test. The p-value therefore cannot convey the range of treatment effects that remains compatible with the observed data.

General explanation: why a confidence interval matters. A confidence interval expresses uncertainty around an estimated effect, in the units of that effect. It helps readers judge which effect sizes are compatible with the data, rather than relying only on whether a test result crosses a threshold. No interval estimate for the paired treatment contrast is reported in the registry record. The bounds listed with the arm summaries are inter-quartile range bounds, not a confidence interval for the comparison.

General explanation: crossover analysis considerations. Crossover designs can improve efficiency when within-person observations are appropriately paired, because people can differ in their baseline levels. The interpretation also depends on design and analysis details: treatment sequence, period effects, possible carryover, and whether participants completed both treatment periods can matter. The registry states the randomized sequences and washout schedule but does not report analyses of these issues. The named signed-rank test indicates a paired method, but the registry does not explain whether other design features were incorporated into the analysis.

General explanation: over-dispersion and skew. When observations vary substantially or have an asymmetric distribution, a mean and standard deviation may not describe the data well. Median and inter-quartile range summaries can be useful in such settings. A rank-based test is another option when a parametric model's assumptions are not suitable. Whether over-dispersion or skew was present in this trial is not reported in the registry record; the choice of a median summary and signed-rank test does not, by itself, establish the reason for those choices.

General explanation: planning illustrations. Planning illustrations use assumptions to show how many participants per arm might be needed under a specified design and target effect. The stated assumptions for the illustrations include a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the target effect is a stated fraction of the observed effect. Such illustrations are not observed power and do not establish the trial's original sample-size justification or design. The registry does not report the protocol's sample-size calculation or the rationale for enrolling 15 participants. The illustration assumptions also do not replace the trial's actual crossover analysis.

The record does not report an adjusted effect estimate, a confidence interval, the test statistic, or analysis details that would permit an independent reconstruction of the primary test. Consequently, the most defensible statistical reading is to distinguish the descriptive summaries from the inferential result: the medians and inter-quartile range bounds describe each treatment condition, while the Wilcoxon signed-rank p-value is the recorded test of the paired comparison. The two kinds of information answer related but different questions.

10. Analyses Reported by the Sponsor

The registry lists a Wilcoxon signed-rank test for the comparison between Veramyst and placebo, with a p-value of 0.33. It also reports treatment-condition medians and inter-quartile range bounds. A separate recalculated paired effect estimate or recalculated p-value is not reported in the registry record, so numerical agreement between a sponsor analysis and an independent recalculation cannot be assessed from these results.

The record does not flag a discrepancy between the reported result and a recalculation. The posted analysis is therefore the available inferential result to describe. It is important not to treat the two condition medians as a substitute for the paired analysis: the crossover comparison depends on the within-participant measurements, which are not posted. Nor can the reported spread bounds be used to reconstruct a treatment-effect confidence interval.

The registry does not include enough detail to determine the exact analysis dataset, the handling of missing paired observations, or the full calculation behind the test. The reported p-value should be read as the result recorded for the primary comparison, with those limitations in view, rather than as a fully reproducible analysis.

11. Multiplicity, Missing Data and Analysis Populations

The registry names one primary outcome, change in tryptase level from baseline to after antigen challenge, and one secondary outcome, total eye symptom scores after antigen challenge. It records two outcome measures and two analyses. The primary result is reported for tryptase; a usable two-condition result for the secondary endpoint is not available in the registry record. The record does not report whether additional outcomes were assessed outside the posted results.

When several outcomes or comparisons are tested, the chance of at least one apparently notable result can increase. Statistical methods can address this issue, but the record does not report a multiplicity adjustment, a hierarchy among tests, or a prespecified testing strategy. The fact that one outcome is labelled primary and another secondary does not establish how multiplicity was handled. The primary p-value should therefore be interpreted with no documented adjustment strategy to account for the listed secondary outcome.

Missing-data methods and analysis populations are also not described. The population field for the primary endpoint is blank, and the record does not state whether the analysis was based on all enrolled participants, participants who completed both periods, or another group. Although 15 participants are listed for each treatment condition, those counts do not establish that every participant had complete measurements in both periods. The number of missing measurements, reasons for missingness, and any imputation or exclusion rules are not reported in the registry record.

These gaps matter particularly for a crossover comparison, which relies on paired observations. If a participant lacks a measurement in either period, the available pairing may change. Without details about completeness and exclusions, readers cannot tell whether the reported analysis represents all enrolled participants or only those with usable paired data. The registry also does not report sensitivity analyses for missing data or alternative analysis populations.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry records zero serious adverse events among 15 participants at risk in the Veramyst condition and zero among 15 at risk in the placebo condition. It also records zero other adverse events among 15 participants at risk in each condition. No serious adverse event terms are listed. The number of deaths is not reported in the registry record; a blank death entry should not be read as a reported zero.

These figures describe the events recorded in the registry. They do not establish that no adverse events occurred outside the recorded categories or observation period, and they do not provide a precise estimate of the frequency of uncommon events. The registry does not report further details about event definitions, collection procedures, timing, severity grading, or how events were attributed to treatment. It also does not provide a comparative safety analysis or uncertainty intervals.

The equal recorded counts across the two treatment conditions are descriptive. In a crossover study, participants may contribute information under both conditions, so the counts should not be interpreted as observations from two independent groups of 15 different people. The registry entries are not enough to establish that the treatments have identical safety profiles.

13. What the Result Does, and Does Not, Mean

The posted results establish what the registry records for this trial: the primary endpoint was tryptase change measured in nasal lavages after one week of treatment, the treatment-condition medians were 0.0 for Veramyst and 2.31 for placebo, and the reported Wilcoxon signed-rank test had a p-value of 0.33. The spread was labelled as an inter-quartile range, with bounds of 0.0 to 11.8 and 0.0 to 8.8, respectively.

Those details do not give a complete estimate of the treatment contrast. The record does not report the paired treatment differences, a contrast estimate, or a confidence interval. Because the exact change calculation is not described, the direction of the change scale is also uncertain. The p-value does not say how large the difference was or how precisely it was estimated. It should not be interpreted as proof that the treatments are equivalent, nor as proof that one condition is better.

The trial's crossover design means the comparison is based on participants receiving both conditions in sequence, but the posted summaries do not show the individual paired responses. Details about treatment period, sequence, carryover, missing observations, and analysis population are not reported in the registry record. These omissions limit assessment of whether the reported comparison fully reflects the intended paired design.

The primary result concerns tryptase, not the secondary outcome of total eye symptom scores. The registry record does not provide a usable result for that secondary comparison, so the primary result cannot answer whether eye symptoms changed or whether eye and nasal symptoms were related. The record also does not support conclusions beyond the studied allergen-challenge setting and the participants represented in this trial.

In general, a statistical result is most informative when the effect estimate, its uncertainty, the analysis population, and the methods are all clear. Here, the available evidence is the registry's descriptive summaries and test result, with limited detail for evaluating precision or reproducing the analysis. Readers can describe what was recorded, but should avoid extending the result to unreported outcomes or treating it as a definitive estimate of the treatment difference.

14. Why This Trial Matters Statistically

This trial is statistically notable because its crossover structure makes the pairing of observations central to the comparison. Each participant was assigned a sequence in which both Veramyst and placebo were used, with a washout period between them. A paired analysis can use each participant as their own comparator, but readers need enough reporting to understand how that pairing was handled. The registry names a signed-rank test, a method generally used for paired data, while leaving important details about the analysis unavailable.

The record also illustrates why descriptive summaries and inferential comparisons should not be conflated. The medians describe the center of the tryptase measurements under each condition, while the test result evaluates a paired comparison under its statistical assumptions. The medians do not reveal the distribution of within-person differences. A contrast estimate and confidence interval would make the magnitude and precision of that paired comparison easier to evaluate, but neither is reported in the registry record.

Another statistical lesson is that a named outcome does not guarantee that its results are available. The registry lists total eye symptom scores as a secondary outcome, but no usable two-condition result for that endpoint is posted. That gap matters because the study's stated purpose includes understanding the relationship between nose and eye symptoms, while the primary endpoint concerns tryptase. The primary result cannot substitute for an analysis of the secondary outcome or of the relationship between outcomes.

Finally, the safety counts and the primary efficacy-style test answer different questions. Zero recorded adverse events in the stated categories are descriptive entries, not a precise comparative safety assessment. The trial's limited enrollment and incomplete reporting of analysis details make careful distinction between recorded observations, test results, and broader conclusions especially important.

15. 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.

Enrollment was 15, and the registry does not report the number of participants with complete paired measurements for the primary endpoint. The listed count of 15 in each treatment condition does not show whether all participants contributed data to both periods. The population field for the primary endpoint is blank, and missing-data rules, exclusions, and analysis populations are not reported in the registry record.

The registry reports condition-specific medians and inter-quartile range bounds, but not the paired treatment differences or a confidence interval for the contrast. It also does not state the exact formula for calculating change, so readers cannot determine from the record which direction on the change scale corresponds to a higher value. The test statistic and detailed implementation of the Wilcoxon signed-rank test are not reported.

Important crossover details are absent. The record does not report analyses of period effects, treatment sequence, carryover, adherence, or protocol deviations. A one-week washout is stated, but the record does not describe its justification or whether any residual effects were assessed. The identities of the people included in triple masking are also not reported.

The secondary eye-symptom outcome is named, but a usable comparison is not posted. The record does not report a multiplicity strategy, a sample-size justification, or the statistical analysis plan. Safety reporting lists zero events in the recorded categories, but does not provide event definitions, collection details, or a reported death count. These limitations restrict reconstruction of the analysis and the precision or scope of conclusions drawn from the registry results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen — NCT00791973.
• Registry record last updated 2014-07-08; status last verified 2014-06.
• Results first posted 2014-07-08.
• 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.

19. Record Summary

This completed Phase 4 trial was randomized, triple-masked and used a crossover design. It enrolled 15 participants with allergic rhinitis. Participants received Veramyst and placebo in different sequences, with each treatment given once daily for one week and a one-week washout period between treatment periods.

The primary outcome was change in tryptase level from baseline to after nasal antigen challenge, measured in nasal lavages and reported in mcg/L. The registry reports a median of 0.0 for Veramyst and 2.31 for placebo, with inter-quartile range bounds of 0.0 to 11.8 and 0.0 to 8.8. The recorded Wilcoxon signed-rank test has a p-value of 0.33.

The record does not report a paired effect estimate, a confidence interval, missing-data methods, or a detailed analysis population. Total eye symptom scores are listed as a secondary outcome, but a usable comparison is not reported. The safety entries record zero serious and zero other adverse events in each treatment condition; the number of deaths is not reported in the registry record.