Fluticasone Nasal Spray Patient Preference Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Fluticasone Nasal Spray Patient Preference Study (NCT00398476), a randomized phase 3 study. The primary outcome is Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing.

2. Clinical Question

The study was designed to evaluate patient preference after single-dose administration of the two nasal sprays. This is a preference question, rather than a direct comparison of symptom improvement or disease control. The overall preference questionnaire offered three responses: preference for FF, preference for FP, or no preference. The questionnaire was completed at the end of crossover dosing.

Participants also completed immediate and delayed attribute questionnaires during the study. The listed secondary outcomes concern preferences and satisfaction related to scent or odor, as well as immediate and aftertaste. These measures describe particular product attributes and should not be treated as interchangeable with the overall preference response.

The registry record identifies 127 enrolled participants and a Per Protocol analysis population defined by completion of both treatment periods and availability at the relevant time points. The number contributing to the primary preference outcome is not reported in the registry record. The record also does not report the counts choosing each response, so the direction and magnitude of the overall preference cannot be established from the posted results.

3. Trial Design

This was a Phase 3 randomized crossover study, listed as completed, with 127 participants enrolled. It concerned perennial allergic rhinitis and compared fluticasone furoate nasal spray with fluticasone propionate aqueous nasal spray. The study objective was to evaluate and compare patient preference following single-dose administration.

In a crossover design, participants receive each of the treatments being compared during separate treatment periods. The registry’s primary outcome population is defined as participants who completed both periods, which is consistent with a within-participant comparison: a participant’s response after one product can be considered alongside that same participant’s response after the other. This design can account for stable differences between participants when the analysis appropriately uses the paired structure. The registry does not report the treatment sequence, the method used to randomize sequence, or details of the interval between treatment periods.

The two products are described as aqueous suspensions with different active ingredients and stated doses: FF 110 mcg and FP 200 micrograms (mcg). The study record gives the composition descriptions but does not report further administration instructions or explain how the doses were selected.

The primary outcome was based on an overall preference questionnaire completed upon completion of crossover dosing. Immediate and delayed attribute questionnaires were also completed during the study. The listed secondary outcomes address scent or odor and taste-related responses. The registry record lists 18 outcome measures and 30 analyses, but does not explain how those analyses were organized or prioritized.

The record gives a study start date of 2006-12-01 and a primary completion date of 2006-12-04. The sample-size justification, planned enrollment rationale, treatment-period details, and any interim analyses are not reported in the registry record. No numerical primary preference results are reported, so the design can be described, but the comparative preference finding cannot be quantified.

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

Washout Period (20 Minutes)

Treatment Period 2

Analysis population for the primary outcome, as defined in the registry: Per Protocol population comprised of all participants who completed both treatment periods. Only those participants available at the indicated time points were analyzed.

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 Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing, measured over Day 1.

The primary endpoint is the number of participants expressing each overall preference response at the end of crossover dosing. The overall preference questionnaire allowed a response favoring FF 110 µg, a response favoring FP 200 µg, or no preference. The registry gives Day 1 as the timeframe and describes the analyzed population as participants who completed both treatment periods and were available at the indicated time points.

A preference endpoint is used to capture participants’ stated choice between products based on the attributes they experienced. It answers a different question from an endpoint measuring symptom change: a stated preference does not, by itself, measure how much symptoms changed or establish which product is more effective. The record does not state how the selected product attributes were combined into the overall response, or whether participants were asked to weigh particular attributes more heavily.

The registry also lists immediate and delayed attribute questionnaires, including questions about scent or odor and taste. Those responses may provide context about specific experiences, but they are not substitutes for the overall preference endpoint. Each addresses a narrower aspect of the product experience.

The endpoint definition is present, but the result is not: the registry record does not report the number of participants preferring either product or reporting no preference. It also does not report a comparison estimate, confidence interval, or statistical test for the primary outcome. Consequently, the endpoint’s measurement and intended interpretation can be explained, but the observed distribution of preferences cannot be described.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a crossover design compare?

In general, a crossover design compares treatments within the same participant by assigning each participant to receive both treatments in separate periods. Each person can act as their own comparison, which can reduce the influence of stable personal characteristics on a treatment contrast. The relevant data are paired: the response under one treatment is linked to the response under the other treatment for that participant.

The registry describes a randomized crossover study and defines the primary analysis population as participants who completed both treatment periods. However, it does not report the treatment sequences, the sequence randomization details, or the analysis method. It is therefore not possible to confirm from the registry how the paired structure was handled. Crossover analyses also need to consider whether effects from an earlier period could carry into a later period, and whether responses can vary by period or sequence. The record does not report how these issues were assessed.

How should a three-response preference outcome be understood?

The overall preference questionnaire offered three choices: preference for FF 110 µg, preference for FP 200 µg, or no preference. This is a categorical outcome. The basic descriptive result would be a count for each response, together with the number of participants contributing responses. A comparative analysis might estimate a difference or another contrast between the response patterns, but the choice of method depends on the study’s analysis plan and the paired data structure.

General statistical interpretation should retain the third category. “No preference” is an intentional response, not necessarily missing data. Treating it as missing or combining it with one of the product-preference categories would alter the endpoint. The registry does not report such recoding, nor does it report the primary response counts or a statistical model.

What do estimates and confidence intervals contribute?

In general, an effect estimate expresses the magnitude and direction of a comparison in a chosen scale. A confidence interval gives a range of values compatible with the observed data and the assumptions of the method; a narrower interval usually indicates greater precision than a wider one. The interval does not correct a biased design, incomplete outcome data, or a poorly chosen analysis. It also does not establish that an effect is clinically important.

The registry record does not report an estimate or confidence interval for the overall preference outcome. Consequently, neither the magnitude nor the precision of the primary comparison can be assessed from the posted record. A test result alone, even if one were reported, would not replace the need to examine the estimate and its uncertainty.

What does multiplicity mean?

In general, multiplicity arises when several outcomes, comparisons, or statistical tests are examined. As the number of tests increases, the chance of obtaining at least one apparently notable result by chance can rise, depending on how the tests relate to one another. Common approaches include identifying a primary endpoint in advance, adjusting significance thresholds, or using a structured testing sequence. The appropriate approach depends on the study objectives and analysis plan.

The registry lists 18 outcome measures and 30 analyses. It does not state which analyses were confirmatory, whether they were prespecified in a statistical analysis plan, or whether any multiplicity adjustment was used. Those details are therefore not reported in the registry record, and the listed counts alone do not establish how the analyses should be interpreted.

Why can missing responses matter?

In general, a missing questionnaire response reduces the information available for the outcome and can affect interpretation if the probability of missingness is related to participants’ experiences or responses. Reporting how many participants were eligible, how many posted an outcome response, and how missing responses were handled helps readers assess this risk. In a crossover trial, incomplete participation in one treatment period can also prevent a paired comparison for that participant.

The registry defines the primary population as participants completing both treatment periods and available at the indicated time points. It does not report the size of that population, the amount or pattern of missing data, or the method used to handle missing responses. No assumption about those procedures can be inferred from the population description alone.

What is the role of planning sample sizes?

In general, sample-size planning estimates how many participants may be needed to detect a prespecified effect under assumptions about variability, allocation, significance level, and desired power. Such estimates are planning illustrations, not observed findings or proof that a study had a particular probability of detecting an effect after completion. Their relevance depends on whether the assumptions match the planned design and analysis.

The registry record does not report a study-specific sample-size justification. It describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Because the primary preference result and the corresponding numerical planning outputs are not reported in the registry record, those assumptions cannot establish the study’s original rationale or the precision of its primary result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures and 30 analyses. It does not identify a hierarchy among all analyses, state which were confirmatory, or describe an adjustment for multiple comparisons. In general, examining many outcomes or tests can increase the chance of finding an apparently notable result by chance. A prespecified primary endpoint and an explicit analysis strategy help readers distinguish a central test from exploratory analyses. That information is not reported in the registry record.

The primary analysis population is described as the Per Protocol population, consisting of participants who completed both treatment periods. Only participants available at the indicated time points were analyzed. The registry does not report how many participants met this definition or how many contributed complete primary endpoint responses. It also does not explain how incomplete questionnaires or missing observations were treated.

In general, excluding participants who do not complete both periods can change the population represented by the analysis, particularly if completion is related to treatment experience or outcome. That is a consideration, not evidence that such a relationship occurred in this study. Without participant flow and missing-data details, the degree to which the analyzed group differs from all enrolled participants cannot be assessed.

The registry does not report an intention-to-treat analysis, an imputation approach, or sensitivity analyses for missing data. It also does not report the statistical method used for the primary preference outcome. These details are important to evaluating the robustness of the result, but their absence from the registry should not be filled in by assumption.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 127 participants at risk in each treatment group. For serious adverse events, it reports 0 in the FF 110 µg group and 0 in the FP 200 µg group; deaths are also reported as 0 in both groups. For other adverse events, it lists 3 participants in the FF 110 µg group and 0 in the FP 200 µg group.

These are descriptive counts. They do not, by themselves, establish whether the groups differ in safety or whether a reported event was caused by a study product. The registry record does not provide descriptions of the other adverse events, a statistical comparison, or a causal assessment. It also does not report further detail about timing, severity, or how adverse events were collected.

Zero reported serious adverse events and zero deaths mean that none were recorded in the listed groups in this registry entry; they do not establish that no such events could occur. The counts should be interpreted within the study record and not as a complete characterization of safety.

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

The study asks a focused question about participant preference for two nasal sprays after single-dose administration. Its randomized crossover design and overall preference questionnaire are suited to describing participants’ stated choices across the two treatment periods. The record also identifies attribute questionnaires concerning scent or odor and taste. These are preference and experience measures, rather than direct measurements of symptom change.

The primary endpoint has three response categories: preference for FF, preference for FP, or no preference. The registry record does not report the number of participants in any category, an effect estimate, or an uncertainty interval. As a result, the posted record does not establish which response was more common, how substantial any preference was, or how precisely it was estimated.

The record does not establish whether one product produced greater symptom relief, improved allergic rhinitis, or was more effective. Those are different questions from stated preference and would require relevant outcome data. Nor can the absence of primary numerical results be interpreted as evidence of equal preference. Without the outcome counts and analysis, neither equality nor a preference for either product can be concluded.

The available safety information is also limited: the registry reports no serious adverse events or deaths in either group, and reports other adverse events for 3 participants in the FF group and 0 in the FP group. These counts alone do not establish a safety difference or causation.

The most defensible reading is therefore narrow. The registry documents a randomized crossover preference study, describes its questionnaire and analysis population, and posts limited adverse-event counts. It does not report enough primary outcome information to quantify or interpret the comparative preference finding.

13. Why This Trial Matters Statistically

Statistically, this study illustrates the distinction between a well-defined research question and a reported result. The registry identifies a randomized crossover comparison and describes a three-category preference endpoint, but the primary outcome counts are not reported. Without those counts, readers cannot assess the direction, size, or precision of the preference comparison.

The crossover design makes the pairing of participant responses central. Analyses that preserve the within-participant relationship can answer a different and often more relevant question than analyses that treat treatment groups as unrelated. The registry’s definition of the Per Protocol population acknowledges completion of both treatment periods as relevant, but the statistical method and number of paired observations are not reported.

The study also shows why outcome structure matters. A response of no preference is substantively different from missing information, and it is not equivalent to a preference for either product. Preserving all three categories is important for describing what the questionnaire asked participants to report.

Finally, the registry lists many outcomes and analyses without describing a multiplicity strategy or the analysis hierarchy. For clinical researchers and biostatisticians, this underscores the value of reporting prespecified primary analyses, participant flow, missing-data handling, and estimates with uncertainty. These details allow a reader to distinguish descriptive findings from confirmatory evidence and to evaluate how robust an interpretation may be.

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 main limitation for interpreting the primary endpoint is that the registry record does not report the response counts for preference for FF, preference for FP, or no preference. It also does not report a comparative estimate, confidence interval, or p-value. The primary question is therefore identifiable, but its result cannot be quantified or interpreted from the registry record.

The record describes a Per Protocol population of participants who completed both treatment periods and were available at the indicated time points, but does not give the population size or participant flow. The amount and pattern of missing questionnaire data, and the handling of incomplete responses, are not reported. This limits assessment of how well the analyzed population represents all enrolled participants.

Important crossover details are also not reported, including the treatment sequence and the interval between periods. The registry does not describe the primary statistical method or report how period, sequence, or possible carryover considerations were addressed. These points matter when evaluating a paired treatment comparison.

The record lists 18 outcome measures and 30 analyses but does not describe their prespecification or a multiplicity strategy. It also does not report a study-specific sample-size justification. The planning assumptions described in the record do not establish the original design rationale, and no numerical primary result is available to judge its precision.

Safety reporting is limited to group counts. Descriptions of the other adverse events and formal safety comparisons are not reported in the registry record. These limitations constrain interpretation; they do not show that a particular analysis or procedure was or was not performed outside what the record reports.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Fluticasone Nasal Spray Patient Preference Study — NCT00398476.
• Registry record last updated 2018-03-01; status last verified 2017-06.
• Results first posted 2018-01-29.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

This completed Phase 3 study was a randomized crossover evaluation of patient preference for fluticasone furoate nasal spray and fluticasone propionate aqueous nasal spray in perennial allergic rhinitis. The registry reports 127 participants enrolled and describes single-dose administration. The primary endpoint was an overall preference questionnaire with choices for FF, FP, or no preference, completed after crossover dosing.

The primary analysis population comprised participants who completed both treatment periods and were available at the relevant time points. The registry record does not report primary preference counts, a treatment comparison estimate, or its precision. It lists 18 outcome measures and 30 analyses but does not report a multiplicity strategy or the primary statistical method.

For safety, the registry lists no serious adverse events or deaths in either group, and other adverse events for 3 participants in the FF group and 0 in the FP group. The record does not provide event descriptions or a formal comparison.