Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS (NCT00519636), a randomized phase 4 study. The primary outcome is Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos.

2. Clinical Question

3. Trial Design

This is a randomized, triple-masked, phase 4, crossover study. The official title describes it as double-blind, placebo-controlled, active-comparator, one-week, crossover, and multicenter; the registry design field records masking as triple. The record lists enrollment of 360. The study status is completed, with start recorded as 2007-08 and primary completion as 2007-11.

A crossover design compares treatments within a participant across treatment periods, rather than assigning every participant to only one treatment for the entire study. The registry lists sequences of FFNS followed by FPNS and FPNS followed by FFNS. It also lists placebo sequences in both orders. These sequences indicate that treatment order was part of the design. The specific method for generating the randomized sequence, allocation concealment, and any washout arrangements are not reported in the registry record.

The official title describes once-daily administration of the active sprays, with doses of 110mcg for FFNS and 200mcg for FPNS. The primary endpoint timeframe identifies baseline, Treatment Period 1 (Days 1-7), and Treatment Period 2 (Days 15-21). The record does not explain the interval between the stated periods or how it was handled analytically.

The stated study purpose is to provide data on subject preference of FFNS compared with FPNS. The listed preference outcomes concern leaking out of the nose or down the throat, ease of use, and gentleness of the mist. The registry also lists active-versus-placebo comparisons for daytime and nighttime reflective nasal symptom scores. Although the official title describes seasonal allergic rhinitis, the condition field lists Rhinitis, Allergic, Perennial; that difference should be kept in mind when characterizing the study population.

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.

Treatment Period 1

Reasons for not completing this period:

Washout Period

Reasons for not completing this period:

Treatment Period 2

Reasons for not completing this period:

Post Study Period

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.

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 Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos, measured over Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21).

The primary endpoint is the comparison of mean change from baseline in daily reflective Total Nasal Symptom Score (rTNSS) over each treatment period for active sprays versus placebos. The score covers rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is rated from 0, meaning none, to 3, meaning severe, and the maximum total score is 12. The record says the mean of the morning and evening scores was used.

Change from baseline expresses the difference between a participant's score during a treatment period and the baseline score. In general, this can help describe whether symptom scores shifted during treatment, while retaining the score's original scale. A comparison of mean changes can summarize the average change across participants in the analysis population. It does not, by itself, describe every participant's experience or the distribution of individual changes.

The record identifies the endpoint as a mean and its dispersion as a standard error. It specifies separate treatment periods, rather than one single follow-up time. The primary outcome is therefore not represented by just one time point or one comparison in the registry listing. No numerical mean changes, standard errors, confidence intervals, or test results for the primary endpoint are reported in the registry record. Without those values, the size and precision of any treatment-period contrast cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous outcome analyzed as a mean, with standard error as the stated dispersion measure. It does not report the numerical estimates or the statistical test used for the primary comparison. The concepts below explain how such summaries are generally read; they do not describe an unreported analysis plan for this particular study.

What does a mean change describe?

For each participant, a change score compares a measurement during a treatment period with a baseline measurement. A mean change then averages those individual changes over the participants included in the analysis. This can answer a group-level question about average movement on the rTNSS scale. The rTNSS is constructed from ratings for four symptoms, with each rated from 0 to 3 and a maximum score of 12. The registry says morning and evening scores were averaged.

A mean is useful for summarizing a continuous measure, but it does not reveal whether most participants had similar changes or whether the mean reflects a mixture of larger improvements and worsening scores. Other descriptions, such as the spread of individual observations or the distribution of changes, can add context. Those summaries are not reported for the primary endpoint in the registry record.

What does a standard error mean?

A standard error describes the sampling uncertainty of an estimated quantity, such as a mean. It is not the same as the standard deviation, which describes variability among individual observations. A smaller standard error generally indicates a more precisely estimated mean under the analysis assumptions, while a larger standard error indicates greater uncertainty. The record names standard error as the dispersion measure but does not give its numerical value for the primary endpoint.

A confidence interval is a common way to communicate estimate uncertainty. It gives a range of values compatible with the data and the method used to calculate the interval. Its interpretation depends on the analysis assumptions and should be considered alongside the estimated effect, not as a replacement for it. Neither a primary endpoint confidence interval nor a numerical effect estimate is reported in the registry record.

Why does crossover design matter?

In a crossover study, participants receive treatments in a sequence, and outcomes can be measured in multiple periods. Comparing treatments within the same participant can account for stable participant characteristics, because those characteristics are shared across periods. However, the periods are not automatically interchangeable. Calendar or period-related changes, treatment order, and residual effects from an earlier treatment may influence later observations. A suitable analysis may need to address these features, depending on the protocol and data.

The registry lists sequences that place FFNS and FPNS in opposite orders, along with placebo sequences in opposite orders. It gives baseline and two treatment-period timeframes for the primary endpoint. It does not report the statistical model, how period or sequence was incorporated, how carryover was assessed, or whether the primary comparison used paired data. Those analysis details are not reported in the registry record, so a specific crossover model should not be assumed.

Why can over-dispersion matter?

As a general statistical concept, over-dispersion arises when observed variability is greater than a model assumes. If an analysis uses a variance assumption that is too small, its uncertainty estimates can be too narrow and statistical tests can appear more conclusive than warranted. The appropriate concern depends on the outcome type and model. Here the primary endpoint is described as a mean of a continuous score, and the registry does not identify an over-dispersion model or any corresponding diagnostic. No claim about over-dispersion in this study can be made from the record.

How should significance and planning calculations be read?

A p-value, when reported, measures how incompatible the observed data are with a specified null hypothesis under a statistical model. It does not measure the probability that a treatment is effective, and it does not show whether an estimated difference is important in practical terms. The registry record does not report a primary endpoint p-value.

The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe detecting a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence about the actual precision or significance of this trial's results. A sample-size illustration calculated from an observed effect is not observed power, and it cannot fill the gap left by absent primary outcome estimates.

What cannot be inferred from the record?

The record does not report a full statistical analysis plan, the hypothesis-testing procedure, covariates, missing-data methods, multiplicity adjustment, or model diagnostics. It also does not report numerical primary outcome results. General statistical explanations can clarify what means, standard errors, confidence intervals, and crossover designs usually involve, but they cannot establish which exact methods were used or what conclusions the trial's analyses reached.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome description and several secondary outcomes, including daytime and nighttime symptom-score comparisons and preferences concerning leakage, ease of use, and mist gentleness. It lists 7 outcome measures and 3 analyses. The primary outcome has multiple categories or time points and is not reduced in the record to one comparison. This creates a set of outcomes and comparisons that readers would ordinarily want to understand together, rather than treating any one result as the only analysis.

When many outcomes or comparisons are examined, the chance of finding at least one apparently unusual result can increase. Statistical approaches to multiplicity can control or describe that issue, but the registry record does not report whether an adjustment was planned or used, nor does it identify a testing hierarchy. Consequently, the role of multiplicity in interpreting the study's intended analyses is not reported in the registry record.

The intended intent-to-treat population is defined as all subjects randomized to study treatment. The record says this population was to form the basis of background, demographic, safety, and efficacy summaries. The number included in each particular outcome analysis, the treatment of missing scores, and any sensitivity analyses are not reported in the registry record. It is therefore not possible to determine from the record whether every randomized participant contributed to every period-specific endpoint summary, or how missing observations may have affected an analysis.

In a crossover trial, missing data may affect one treatment period, both periods, or the ability to make a within-participant comparison. How those patterns were addressed depends on the analysis plan and available data. No missing-data method or analysis-population details beyond the stated intent-to-treat definition are reported in the registry record. No assumptions about imputation, exclusions, or complete-case analysis should be made.

11. 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 registry reports serious adverse events by spray group as participants at risk and participants affected. For Fluticasone Furoate Nasal Spray, 166 were at risk and 0 were affected. For Fluticasone Propionate Nasal Spray, 159 were at risk and 0 were affected. For Placebo - FF, 174 were at risk and 0 were affected. For Placebo -FP, 166 were at risk and 0 were affected. These are the recorded serious-adverse-event counts; they do not establish that no events occurred outside the recorded groups or reporting period.

The same entries list other adverse events: 7 affected among 166 at risk for Fluticasone Furoate Nasal Spray, 14 among 159 for Fluticasone Propionate Nasal Spray, 12 among 174 for Placebo - FF, and 12 among 166 for Placebo -FP. The record does not provide event terms in this summary, and the serious-event terms list is empty. The listed deaths field is null, so deaths are not reported in the registry record.

These group counts should not be treated as a complete safety profile or as a direct estimate of comparative risk. The registry record does not describe event severity beyond the serious-versus-other grouping, timing, duration, treatment attribution, or how crossover exposure was handled in these summaries. Zero recorded serious events is a limited observation in this record, not proof that serious events are impossible.

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

The registry record establishes that a randomized, masked, crossover study was conducted to examine nasal-spray characteristics, patient preference, and symptom scores for FFNS and FPNS, with placebo sprays also included. It defines an rTNSS endpoint and identifies preference questions about leakage, ease of use, and gentleness of the mist. These details describe what the trial was designed to assess, not what the numerical findings were.

The primary endpoint result is not reported in the registry record. There is no numerical mean change, uncertainty estimate, confidence interval, or p-value in the record to support a statement about the observed active-versus-placebo comparison. Likewise, the registry does not provide numerical results for the stated patient-preference questions. The design and stated aims alone cannot establish which spray participants preferred or how symptom scores changed.

The record's safety entries report zero participants affected by serious adverse events in each listed group, together with counts for other adverse events. These data are limited to the categories and counts recorded. They do not provide enough detail to characterize all events or establish a comparative safety conclusion. Deaths are not reported in the registry record.

In general, statistical estimates need to be considered with their uncertainty, analysis population, outcome definition, and analysis methods. Here, the stated intent-to-treat population and endpoint definition offer useful context, but numerical outcome estimates and key analysis details are absent. Therefore, this record supports a description of the design and registered outcomes, but not an inference about the magnitude, precision, or statistical significance of the primary comparison.

Any planning illustration based on an observed effect is not an observed trial result and is not observed power. It depends on its stated assumptions and does not replace estimates from the trial data. No medical advice or treatment conclusion follows from the design description or the limited event counts alone.

13. Why This Trial Matters Statistically

This trial is statistically notable for its crossover structure and its combination of symptom-score and preference questions. A crossover can allow treatment comparisons within participants, which is a different comparison structure from a parallel-group trial. That feature also makes treatment order and period-specific observations important to interpretation. The registry identifies two treatment periods and opposite treatment sequences, but does not report how these features were handled in the analysis.

The endpoint is a repeated symptom measure summarized as mean change from baseline. The rTNSS is assembled from four symptom ratings and has a maximum score of 12. Using a defined scale makes the outcome interpretable in terms of symptom ratings, while averaging morning and evening scores produces a daily summary. To assess a treatment contrast, readers would also need the actual estimates and their uncertainty, which are not reported in the registry record.

Preference is a distinct kind of outcome from symptom change. A preference question about leakage, ease of use, or mist gentleness addresses the participant's experience of the spray, while rTNSS reflects reported nasal symptoms. Considering both types of outcomes can broaden a study's questions, but the registry's stated aims do not supply their numerical findings. They should not be treated as interchangeable measures.

The registry record also illustrates why design descriptions and results need to be read separately. It gives a completed status, population definition, endpoint specification, and group-level safety counts, yet the principal efficacy and preference estimates are not reported. Without those estimates and the associated analysis details, the main statistical comparisons cannot be evaluated for size or precision. The record is informative about what was planned and recorded, but incomplete as a basis for judging the trial's quantitative findings.

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.

A central limitation for interpreting this trial from the registry record is the absence of numerical results for the primary rTNSS endpoint and the stated preference outcomes. No means, standard errors, confidence intervals, or p-values are reported for the primary comparison. The registry therefore does not permit assessment of the observed effect's direction, magnitude, or precision.

The population description is not fully consistent across the record: the official title refers to adult subjects with seasonal allergic rhinitis, while the condition field lists Rhinitis, Allergic, Perennial. The record does not explain this difference. The listed enrollment is 360, but participant counts contributing to each efficacy period or preference analysis are not reported.

Important design and analysis details are not reported in the registry record. These include the sequence-generation and allocation procedures, any washout arrangements, the statistical model for the crossover comparisons, treatment of period and sequence, carryover assessment, missing-data methods, and multiplicity handling. The intent-to-treat population is defined, but the record does not show whether all randomized participants were included in every endpoint analysis.

The safety entries are also limited. They provide counts of participants affected by serious and other adverse events, but not event descriptions, timing, severity details beyond the category, or attribution. The deaths field is null, and deaths are not reported in the registry record. The serious adverse event terms list is empty. These limitations restrict interpretation to the recorded counts rather than a full assessment of the type or pattern of events.

Finally, the one-week description in the official title appears alongside specified treatment periods of Days 1-7 and Days 15-21. The record does not explain that timing or the interval between periods. No further detail about duration or conduct should be inferred from those labels alone.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS — NCT00519636.
• Registry record last updated 2016-12-09; status last verified 2016-10.
• Results first posted 2010-01-15.
• 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.

18. Record Summary

NCT00519636 is a completed, randomized, triple-masked, phase 4 crossover study sponsored by GlaxoSmithKline. The registry lists enrollment of 360 and describes a comparison of fluticasone furoate nasal spray, fluticasone propionate nasal spray, and matching placebo sprays. The official title describes adult subjects with seasonal allergic rhinitis, while the condition field lists Rhinitis, Allergic, Perennial.

The primary outcome is mean change from baseline in daily reflective Total Nasal Symptom Score over treatment periods. The score covers four symptoms, ranges from 0 to a maximum of 12, and uses the mean of morning and evening ratings. Secondary outcomes include daytime and nighttime symptom scores and preferences concerning leakage, ease of use, and mist gentleness.

Numerical primary efficacy and preference findings are not reported in the registry record. Serious adverse events affected 0 participants in each listed group; other adverse event counts are also recorded. Deaths are not reported in the registry record. The statistical model, missing-data methods, and multiplicity approach are not reported.