Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis (NCT00979615), a randomized phase 4 study. The primary outcome is Mean Change in 2-week rTNSS From Baseline.

2. Clinical Question

3. Trial Design

The registry identifies this as a Phase 4, randomized, quadruple-masked, parallel-group study. The two arms received olopatadine HCL nasal spray, 0.6%, or azelastine HCl nasal spray, 137 mcg. Because both arms used active medications, the comparison concerns these two treatments as studied; it does not estimate either treatment’s effect against placebo. The registry lists Alcon Research as the sponsor and the study status as completed.

The recorded enrollment was 129. For the primary outcome, the posted summary statistics include 57 participants in the olopatadine arm and 58 in the azelastine arm. Those outcome-specific counts do not describe every enrolled participant, and the reason for the difference between enrollment and the outcome counts is not reported in the registry record. The registry lists a study start of 2009-09 and a primary completion of 2009-11.

The primary endpoint was mean change in the two-week reflective total nasal symptom score from baseline. The registry describes this score as based on patient-completed diaries. Four symptom assessments were combined into a total score, with reflective ratings referring to the hour since the last dose of study medication. Four secondary symptom outcomes are identified: rhinorrhea, postnasal drip, nasal congestion, and sneezing. Detailed numerical secondary results are available in the registry record for rhinorrhea, postnasal drip, and nasal congestion; results for sneezing are not reported in the registry record.

The allocation ratio, sequence-generation method, concealment procedures, exact masking roles, and treatment adherence are not reported in the registry record. The original sample-size justification and the trial’s planned statistical analysis are also not reported. Randomization and masking are features of the design, but without the missing operational details they do not, on their own, establish how every potential source of bias was addressed.

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

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 Mean Change in 2-week rTNSS From Baseline, measured over 2 week.

The primary endpoint was mean change from baseline in the reflective total nasal symptom score after 2 weeks. The registry’s title calls it rTNSS, while its description calls the composite TVSS or rTVSS. The description makes clear that the measure combines ratings of nasal congestion, rhinorrhea, postnasal drip, and sneezing. Each symptom was rated from 0 (none) to 3 (severe), in whole units, and the four ratings were totaled to give a maximum possible score of 12.

Patient-completed diaries were used to record the symptoms. The reflective rating concerned the hour since the last dose of study medication. A composite endpoint can represent several related symptoms in one measure, rather than treating a single symptom as the full account of nasal symptom burden. The component outcomes were also identified as secondary outcomes, allowing the record to describe individual symptom scores separately.

The registry reports arm means and standard deviations for the primary measure at the two-week assessment, along with the number of participants contributing to those summaries. It does not report baseline means, individual change data, or the sign convention that maps the reported change values to symptom improvement or worsening. Therefore the numeric direction of the posted mean change should not be interpreted as improvement or worsening without that information. The endpoint is a symptom score, not a direct measure of a clinical event or a broader health outcome.

7. Results Posted in the Registry

• Azelastine HCl: mean 6.50 versus 5.90 on control; difference 0.60 (95% CI -0.38 to 1.58), standardized effect d = 0.22; z-test p = 0.229.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean Change in Rhinorrhea Reflective Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Azelastine HCl: mean 1.30 versus 1.50 on control; difference -0.20 (95% CI -0.64 to 0.24), standardized effect d = -0.19; z-test p = 0.375.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Azelastine HCl and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change Postnasal Drip Reflective Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Azelastine HCl: mean 1.80 versus 1.50 on control; difference 0.30 (95% CI -0.15 to 0.75), standardized effect d = 0.28; z-test p = 0.186.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Azelastine HCl and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change Nasal Congestion Reflective Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Azelastine HCl: mean 1.70 versus 1.40 on control; difference 0.30 (95% CI -0.18 to 0.78), standardized effect d = 0.26; z-test p = 0.224.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Azelastine HCl and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes examine individual symptoms that also contribute to the composite primary score: rhinorrhea, postnasal drip, nasal congestion, and sneezing. The registry identifies all four as secondary outcomes. Detailed numerical results are reported for rhinorrhea, postnasal drip, and nasal congestion; results for sneezing are not reported in the registry record.

Across the three secondary outcomes with detailed results, the arm contrasts do not all point in the same numerical direction. The rhinorrhea mean is lower in the azelastine arm, while the postnasal drip and nasal congestion means are higher in that arm. The unadjusted confidence intervals for those comparisons include zero. This mixed pattern does not offer a consistent symptom-specific direction that would change the overall reading of the primary result. It also cannot establish whether differences in individual components account for the composite score.

Secondary results can help describe which symptoms contribute to a composite outcome, but they are generally less decisive when multiple outcomes are examined and the analysis plan is unavailable. Each comparison adds another opportunity for a chance finding. The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or formal secondary analyses. The available comparisons are therefore descriptive and exploratory rather than a basis for multiple independent confirmatory claims.

The secondary outcomes should be considered alongside, not substituted for, the primary endpoint. The primary comparison itself is an unadjusted recalculation with an interval including zero. The secondary results do not resolve the uncertainty in that primary estimate, and the lack of reported sneezing results leaves one of the listed symptom outcomes without a detailed numerical account.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean Change in Rhinorrhea Reflective Score
• Mean Change Postnasal Drip Reflective Score
• Mean Change Nasal Congestion Reflective Score
• Mean Change in Sneezing Reflective Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary measure is continuous: it is a numeric score formed by adding symptom ratings, and the registry reports a mean and standard deviation for each arm. A mean describes the average score change among the participants contributing to the summary. A standard deviation describes the spread of participant values around that mean. It is not the same quantity as the uncertainty in the estimated mean or the uncertainty in the difference between arms.

What does the mean difference represent?

The comparison is expressed as the azelastine mean minus the olopatadine mean. For the primary measure, the posted means are 6.5 and 5.9, and the unadjusted recalculation gives a difference of 0.6. A positive value means the reported mean in the azelastine arm is numerically higher under this subtraction convention. It does not, without the change-score sign convention, establish whether that numerical direction represents better or worse symptoms. The registry’s score description says that higher symptom ratings correspond to greater severity, but the direction in which change was calculated is not specified in the record.

The arm-level standard deviations are 2.3 for azelastine and 3.0 for olopatadine. Their difference in size indicates that the observed scores have different spreads in the two arms. The recalculated comparison uses the posted summaries and an unadjusted method. It is not a reconstruction of any unreported baseline-adjusted, covariate-adjusted, or model-based analysis. The registry record does not describe such analyses.

How should the confidence interval be understood?

A confidence interval describes uncertainty around an estimated difference under the method used to calculate it. It gives a range of values compatible with the observed data and the assumptions of that method; it is not a range containing a fixed proportion of individual participants’ scores. For the primary comparison, the interval includes zero. Zero corresponds to no difference in the arm means under the stated subtraction convention. Since the interval also includes values on either side of zero, it does not isolate a single direction of difference.

The confidence interval is an unadjusted recalculation from summary statistics. It should be interpreted together with the limitations of that calculation and the absent analysis plan. It does not incorporate any adjustment that is not represented by the posted arm summaries. The registry’s lack of reported analyses means that the actual planned inferential procedure, if any, cannot be compared with this calculation.

What does a p-value say?

The primary unadjusted p-value is 0.229. In general, a p-value measures how unusual results at least as incompatible with a null hypothesis would be under that hypothesis and the statistical model used. It is not the probability that the null hypothesis is true, and it does not quantify the size or clinical importance of an effect. It also does not show that two treatments are equivalent. The value depends on assumptions and the analysis procedure; the registry does not report a formal analysis plan against which to assess those choices.

The reported p-value is not a substitute for the estimated difference and its confidence interval. The estimate gives the direction and size of the observed contrast in the scale’s units, while the interval communicates uncertainty around that estimate. Neither should be interpreted without considering the study design, participant counts, outcome definition, and reporting gaps.

Why does variability matter?

Greater variability makes an average less precise when the number of observations is held fixed, because individual scores differ more widely around the mean. In clinical symptom outcomes, variability may arise from differences among participants, day-to-day fluctuations, measurement, or other factors. The registry does not quantify the sources of variation in this study. The posted standard deviations summarize the overall observed spread, not its causes.

Over-dispersion is a general concern when a statistical model assumes less variability than the data actually contain. In that situation, standard errors may be too small and confidence intervals too narrow. The primary endpoint is summarized as a continuous score, and the registry record does not report a dispersion diagnosis or a model that would permit a specific over-dispersion assessment. The general issue is relevant to statistical modeling, but it should not be asserted as a demonstrated problem in these data.

What is recalculated rather than reported?

The registry supplies arm-level means, standard deviations, and participant counts for the primary outcome. The difference, confidence interval, and p-value discussed in the comparison are simple unadjusted recalculations from those posted summary statistics. The registry record lists no reported analyses. The recalculation therefore offers a transparent descriptive comparison, but it cannot recover individual-level data, confirm the handling of missing observations, or reproduce an analysis plan that is not reported.

The same distinction applies to the secondary comparisons. Their arm-level means and standard deviations support unadjusted comparisons, but the registry record does not report formal secondary analyses. Because several symptom outcomes are considered, chance findings become a concern when each is examined separately. Without a reported multiplicity plan, the secondary p-values should not be treated as a collection of confirmatory tests.

Statistical methods can describe evidence and uncertainty, but interpretation also requires a clear estimand: the precise treatment contrast, outcome, time point, and participant population of interest. The registry identifies a two-week change score and two active treatment arms. It does not report a detailed estimand, the approach to treatment discontinuation, or how missing diary entries were handled. Those omissions limit how specifically the calculated comparison can be connected to a planned clinical question.

11. Confidence Intervals and Precision

The primary unadjusted mean difference is 0.6 in the stated direction, azelastine minus olopatadine. Its confidence interval includes zero. This means the recalculated data do not estimate the difference with enough precision to rule out no difference under the method used. The interval also spans values on either side of zero, so the data do not determine the direction of the underlying mean contrast with certainty.

Precision is distinct from statistical significance and from clinical importance. A wide interval indicates that the estimate remains uncertain; a narrow interval can still describe an effect too small to matter, depending on the clinical context. The registry does not state a threshold for a clinically meaningful score difference, so the interval cannot be judged against such a threshold. It also does not report an equivalence or non-inferiority margin.

The primary outcome counts are 57 for olopatadine and 58 for azelastine, while enrollment was 129. The registry record does not explain the difference in counts or report how missing primary outcome data were handled. If the outcome summaries are based on only participants with available scores, the uncertainty calculation does not by itself account for possible differences between participants with and without recorded outcomes.

The confidence interval is an unadjusted recalculation from summary statistics, not a registry-reported interval from a documented analysis plan. It should therefore be read as a measure of uncertainty under that calculation, rather than as a complete account of uncertainty under every possible analysis. The posted arm summaries permit a comparison but do not resolve issues involving missingness, baseline adjustment, or analysis-population selection.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures express the number of participants needed in each arm, not a combined total and not total events. The planning illustration is based on the observed effect or a stated fraction of that effect, with two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. For time-to-event outcomes, the general convention would be total events, but this trial’s outcomes are continuous, so the figures are participants per arm.

The 80% power column describes the planned sample size at which a study would have an 80% chance of detecting the specified effect under the stated assumptions, if that effect were the true one and the model assumptions held. The 90% power column uses a higher probability of detecting that same specified effect, so it requires a larger planned sample. These are planning quantities rather than descriptions of the study’s observed results.

The planning rows use 100%, 75%, and 50% of the observed effect. For the primary outcome, the corresponding figures are 311, 553, and 1,244 participants per arm for 80% power, and 417, 740, and 1,665 participants per arm for 90% power. The pattern illustrates that smaller effects require more participants to detect, all else held constant. It does not say what the original trial designers expected or used when planning this study. The original design assumptions and sample-size justification are not reported in the registry record.

This is not observed power. It is a planning illustration using an effect estimated from the observed data, and it can be unstable when that estimated effect is uncertain. The enrolled sample and the counts contributing to the primary outcome are the observed study counts; the planning figures do not change or reinterpret those counts.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.600; pooled standard deviation σ = 2.670.
2. n = 2 × (1.96 + 0.842)² × 2.670² / 0.600² = 310.8, rounded up to 311 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.6                      # observed difference in means
sigma <- 2.66994083657231                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(979615)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 311 (80% power), 417 (90% power)
 75% of observed effect: n per arm = 553 (80% power), 740 (90% power)
 50% of observed effect: n per arm = 1,244 (80% power), 1,665 (90% power)
power.t.test: 311.8 
Simulated power at n = 311 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and several secondary symptom outcomes, but the statistical plan is not reported in the registry record. It is therefore not possible to determine whether the study prespecified a testing hierarchy, adjusted for multiple comparisons, or treated secondary analyses as exploratory. The registry lists no reported analyses. The unadjusted recalculations do not make an adjustment for examining multiple outcomes.

Multiplicity matters because conducting several tests can increase the chance that at least one result appears notable through random variation, even when there is no underlying effect. This is a general statistical concern, not a claim that any particular secondary result is false. Without the trial’s planned approach, separate secondary p-values should not be interpreted as if each were the only analysis conducted. The missing formal analysis record also prevents assessment of whether the reported endpoint and time point were selected according to a prespecified plan.

The registry record does not report the analysis population, such as whether the primary analysis included all randomized participants or only participants with observed outcome data. The primary outcome summaries include 57 participants in the olopatadine arm and 58 in the azelastine arm, compared with recorded enrollment of 129. For the detailed secondary outcomes, the arm counts are 44 and 43. The record does not explain these outcome-specific counts or state whether missing scores, diary entries, or participant withdrawals account for them.

Missing-data methods are also not reported. It is not known whether incomplete diary data were excluded, imputed, or handled through another approach, nor whether the timing or amount of missing information differed by arm. These are important because an analysis based on participants with complete scores can be biased if the availability of scores is related to symptom experience or treatment assignment. The registry record does not provide enough information to assess that possibility.

The record does not report baseline score distributions, baseline adjustment, protocol deviations, adherence, or sensitivity analyses. Their absence does not establish that such procedures were not performed; it means that they cannot be evaluated from the registry record. These gaps constrain confidence in the analytical interpretation, even though the posted arm-level summaries permit an unadjusted comparison.

15. 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.

Most frequent non-serious adverse event terms

The serious adverse event summaries list 63 participants at risk in the olopatadine group and 66 in the azelastine group. No participants in either group are recorded as having a serious adverse event: 0 in each arm. The registry’s serious adverse event terms list is empty. These are the reported counts for the safety summary, not the primary outcome counts.

A count of zero means no serious events were recorded in these groups during the reporting period represented by the registry entry. It does not establish that the risk is zero, and it does not rule out uncommon events. The registry record does not provide event terms or further detail for serious events, and deaths are not reported in the registry record.

Other, non-serious adverse events are recorded for 5 participants in the olopatadine group and 9 in the azelastine group, among the respective groups of 63 and 66 at risk. The registry summary does not give additional detail about those events in the registry record for this analysis. Safety counts should be read as descriptive observations from this study, not as proof of comparative safety or a complete account of risk.

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

The registry record describes a randomized comparison of olopatadine and azelastine in participants with vasomotor rhinitis, with a primary symptom-score assessment after 2 weeks. For the primary endpoint, the posted group means are 5.9 and 6.5, and an unadjusted recalculation gives a mean difference of 0.6 in the direction azelastine minus olopatadine. The interval includes zero and the unadjusted p-value is 0.229. These figures describe the observed summaries and the uncertainty of that recalculation; they do not establish that either treatment is superior.

The result also does not establish that the treatments are equivalent. Equivalence requires a prespecified margin and an analysis designed to determine whether the difference lies within that margin. The registry record reports no equivalence or non-inferiority margin. A comparison that does not clearly distinguish a difference from no difference is not, by itself, evidence that the treatments have the same effect.

The score is a composite of four nasal symptoms and the endpoint is described as a change from baseline. The registry does not report the baseline summaries or state the sign convention used for change. Consequently, the positive arm means and positive mean difference should not be translated into symptom improvement or worsening based solely on their signs. The outcome count and spread information also do not give individual trajectories or reveal how scores changed for particular participants.

The results do not provide a basis for medical decisions. They concern this study’s reported symptom scores and safety counts, with limits from absent analyses, missing-data methods, analysis-population details, and clinical-importance thresholds. The secondary outcomes are not a substitute for the primary result, and detailed results for sneezing are not reported in the registry record. A complete understanding of the study’s intended inferential claims would require information not present in the registry record.

17. Why This Trial Matters Statistically

This trial is statistically instructive because a randomized, masked, active-comparator design can still leave substantial uncertainty when the registry record contains only outcome summaries and no formal analysis report. The randomization and quadruple masking are important design features, but they do not eliminate the need to understand the analysis population, handling of missing scores, and prespecified statistical plan.

The primary outcome is a composite score assembled from four symptom ratings. That construction makes the result a summary of several related domains, while the secondary outcomes separate some of those domains. The distinction matters: a composite can provide a broad outcome measure, but its mean may conceal component patterns that point in different numerical directions. The secondary data in this record show why the component results should be interpreted cautiously and alongside the primary endpoint.

The comparison also illustrates the difference between a point estimate and precision. A mean difference of 0.6 is an estimate, not a definitive statement about the underlying contrast. The confidence interval includes zero, and the registry does not give a clinical-importance threshold to help judge the practical meaning of plausible differences. Statistical uncertainty and clinical relevance are separate questions.

Finally, planning illustrations based on the observed effect can show how required sample size changes as the target effect becomes smaller. They cannot reconstruct the original design rationale or determine whether the completed trial was adequately planned. The original sample-size justification is not reported in the registry record. Keeping planning quantities distinct from observed enrollment, and unadjusted recalculations distinct from reported analyses, is essential to a disciplined reading of the evidence.

18. 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 leaves several trial-specific questions unresolved. Although the study is identified as randomized and quadruple-masked, it does not describe sequence generation, allocation concealment, the roles included in masking, or how masking was maintained. The allocation ratio and site information are not reported in the registry record. These omissions make it difficult to assess implementation details that could affect risk of bias.

The primary outcome is labeled rTNSS in its title and rTVSS in its description. The description defines a four-symptom composite, but the record does not state the direction convention for the change score. It also does not provide baseline values or a clinical-importance threshold. This limits interpretation of the score’s direction and the practical meaning of the estimated contrast.

The primary outcome counts are lower than total enrollment, and the detailed secondary results have smaller arm counts still. The reasons are not reported in the registry record. No missing-data method, analysis population, adherence information, or sensitivity analysis is reported. The listed secondary outcomes include sneezing, but detailed numerical results for that outcome are not reported in the registry record.

The registry reports no formal analyses or statistical plan, including no information about multiplicity, covariate adjustment, or prespecified handling of the secondary outcomes. The inferential comparisons discussed are unadjusted recalculations from summary statistics, so they cannot address individual-level modeling or recover the trial’s original analysis. The sample-size justification is likewise not reported, and the planning illustration based on observed effects is not a substitute for it.

Safety reporting is limited to group counts for serious and other adverse events. Serious event terms are not listed, and deaths are not reported in the registry record. The available summaries support a concise description of recorded counts, but not a comprehensive assessment of comparative safety.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis — NCT00979615.
• Registry record last updated 2011-05-10; status last verified 2011-04.
• Results first posted 2011-05-10.
• 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.

22. Record Summary

NCT00979615 is a completed Phase 4 randomized, quadruple-masked, parallel-group study sponsored by Alcon Research. It enrolled 129 participants with vasomotor rhinitis and compared olopatadine HCL nasal spray, 0.6%, with azelastine HCl nasal spray, 137 mcg. The recorded study start was 2009-09, and primary completion was 2009-11.

The primary endpoint was mean change from baseline in a reflective composite nasal symptom score after 2 weeks. The posted arm means were 5.9 for olopatadine and 6.5 for azelastine. The unadjusted recalculated mean difference was 0.6, with p = 0.229 and a confidence interval that includes zero. The registry record reports no formal analyses, analysis plan, or original sample-size justification.

Secondary outcomes covered four nasal symptoms; detailed numerical results are reported for three. Serious adverse events were recorded for 0 participants in each group. Interpretation is limited by unreported analysis populations, missing-data handling, change-score direction, and clinical-importance criteria.