Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) (NCT00346775), a randomized phase 3 study. The primary outcome is Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores.

2. Clinical Question

The study’s stated main goal was to validate the EARNS-Q Preference Module and test reliability using the Treatment Satisfaction Questionnaire for Medicines (TSQM), described in the registry as a validated satisfaction questionnaire. The official title describes a three-week crossover study. The primary outcome covers Day 1 to Day 23 and relates preference scores to changes in TSQM domains and mean daily rTNSS.

These questions concern whether questionnaire responses behave in ways consistent with treatment satisfaction and symptom changes. They do not, by themselves, establish that either nasal spray is more effective, safer, or preferable for patients generally. The record also lists a secondary outcome counting participants with a preference for Nasarel or Beconase AQ at the end of the last crossover period. Numerical results for that preference outcome are not reported in the registry record.

3. Trial Design

This was a randomized, single-blind, multicenter, Phase 3 crossover study, with enrollment of 97 and status recorded as completed. The official title describes adults with seasonal allergic rhinitis and a three-week crossover study. The condition listed separately in the registry record is perennial allergic rhinitis, so those descriptions do not match exactly.

In a crossover design, participants receive more than one treatment over successive periods, with each participant potentially contributing observations under multiple treatments. General explanation: this can make within-participant comparisons useful because characteristics that remain stable within a participant do not vary across their treatment periods. The analysis still needs to account appropriately for period, sequence, and possible carryover effects. The registry record does not report whether or how those issues were assessed.

The treatments named in the intervention record are beclomethasone dipropionate and flunisolide. Random allocation and single masking are reported, but the identity of the person or group masked is not reported in the registry record. The allocation sequence, treatment order, details of masking, doses, and any washout interval are also not reported in the registry record. The official title describes the study as multicenter, but the number or locations of centers are not reported.

The primary analysis population is described as all participants randomized to study drug. The record gives a primary outcome timeframe of Day 1 to Day 23 and defines changes as Treatment Period 2 scores minus Treatment Period 1 scores. It does not report the number of participants who completed each period or whether all randomized participants contributed to every outcome. The enrollment figure is not a measure of the number included in each particular analysis.

The record lists one primary outcome and secondary outcomes involving mean rTNSS over a period and preference at the end of the last crossover period. It does not report a protocol-based sample-size rationale or a detailed statistical analysis plan. The planning illustrations associated with the analysis are not the trial’s own design justification and should not be mistaken for observed power.

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: A total of 97 participants were randomized for the study in a crossover manner in a ratio of 1:1 to one of two blinded treatment groups of 116 microgram (µg) Nasarel or 168 µg Beconase AQ® metered dose nasal spray to be administered twice daily for 1 week. The study consisted of 2 treatment periods of 1 week each and 1 washout period of 7 days.

Period 1: Intervention Period 1

Reasons for not completing this period:

Period 2: Washout Period (7 Days)

Period 3: Intervention Period 2

Analysis population for the primary outcome, as defined in the registry: Intent- to- Treat (ITT) Population was defined as all the participants who were randomized to the study drug. Pearson correlations was used in correlational analyses.

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 Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores, measured over Day 1 to Day 23.

The primary outcome concerns correlations between EARNS-Q Preference Module scores and two kinds of change: changes in TSQM domain scores and changes in mean daily reflective Total Nasal Symptom Scores (rTNSS). The registry specifies the timeframe as Day 1 to Day 23. It defines each change as the Treatment Period 2 score minus the Treatment Period 1 score.

The EARNS-Q Preference Module is described as covering efficacy, sensory perception, device characteristics, spray delivery, overall product preference, and a total domain. TSQM domains include global satisfaction, convenience, effectiveness, and side effects. The stated interpretation is that positive correlations between preference scores and TSQM changes indicate that preference is associated with better TSQM scores. Negative correlations between preference and mean daily rTNSS changes indicate that preference is associated with lower mean daily rTNSS.

As a general statistical concept, correlation describes the direction and strength of an association between two measured quantities. It does not establish that one quantity caused the other to change. Correlations can help evaluate whether a questionnaire’s scores relate to other measures in expected ways, which is relevant to assessing questionnaire validity. The registry record does not report the numerical correlation coefficients, their uncertainty intervals, or their significance tests, so the size and precision of these associations cannot be evaluated from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary analysis is described as correlational, using Pearson correlations in the Intent-to-Treat population. The record defines this population as all participants randomized to study drug. The outcome description links EARNS-Q Preference Module scores with changes in TSQM domain scores and mean daily rTNSS. It defines those changes as Treatment Period 2 minus Treatment Period 1.

What does a Pearson correlation measure?

General explanation: Pearson’s correlation summarizes the direction and strength of a linear relationship between two quantitative variables. A positive value indicates that higher values of one variable tend to occur with higher values of the other; a negative value indicates that higher values of one tend to occur with lower values of the other. A value close to zero indicates little linear association, though a non-linear pattern could still exist. Correlation is not evidence of causation.

In this study, one variable is an EARNS-Q preference score and the other is a change score from a TSQM domain or mean daily rTNSS. The clinical interpretation depends on how the scores are coded. The registry gives a specific sign convention: positive TSQM change and negative rTNSS change correspond to preference for the product in Treatment Period 2. Those conventions help explain the expected directions, but they do not substitute for seeing the estimated correlations.

Why use change scores?

General explanation: a change score expresses how a participant’s measured value differs between two specified times or periods. It can focus the analysis on within-participant movement rather than the absolute score at only one time point. Here, the periods are Treatment Period 1 and Treatment Period 2. A change score also depends on the order of subtraction, so reversing the order would reverse its sign. The registry explicitly defines the subtraction order, which is necessary for interpreting the stated positive and negative relationships.

Change scores can be affected by measurement error in either period. In a crossover study, period and sequence may also matter: scores could differ because of time, order, or residual effects from a prior treatment rather than treatment preference alone. General explanation: crossover analyses often need to consider these design features. The registry record does not describe whether they were assessed, or whether Pearson correlations were adjusted for any such factors.

What does the analysis population mean?

The record defines the Intent-to-Treat population as all participants randomized to study drug. This definition identifies the intended analysis population but does not state how missing observations were handled. It is not reported whether every randomized participant had usable EARNS-Q, TSQM, and rTNSS measurements, whether participants with incomplete data were excluded from particular correlations, or whether any imputation method was used. The number analyzed for each correlation is not reported in the registry record.

General explanation: estimates based on participants with complete measurements can differ from estimates that include participants with incomplete data, particularly if missingness is related to outcomes or treatment experience. The amount and pattern of missing data, and the method used to address it, are therefore relevant to judging reliability and generalizability.

How should precision be judged?

A correlation estimate alone would describe the observed association in the analysis sample. A confidence interval would show the range of values reasonably compatible with the data under the statistical model, and would convey precision. A p-value would address how compatible the data are with a specified null hypothesis, under the assumptions of the test. These measures answer different questions: statistical evidence against a null does not tell readers whether an association is large or useful, and an estimate without an interval can be difficult to interpret precisely. Numerical coefficients, confidence intervals, and p-values are not reported in the registry record.

General explanation: Pearson correlation is most directly informative about linear association and can be sensitive to outlying observations. Its usual inferential interpretation relies on assumptions about the data and sampling process. The record does not report checks of those assumptions, diagnostic analyses, or alternative correlation methods.

What do the planning illustrations represent?

The planning illustrations are described as calculations based on the observed effect, not the study’s original design. Their assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. These are planning assumptions, not results from the trial and not evidence of observed power. The record does not provide a sample-size justification from the original protocol. Because the primary outcome is a crossover correlation analysis, the illustrations’ two-arm assumptions should not be read as a full description of the primary analysis design.

General explanation: over-dispersion refers to variability greater than a statistical model expects. When present, it can make uncertainty estimates too small if ignored. The registry does not say that over-dispersion was relevant to this correlation analysis; it is a general consideration in statistical modeling rather than a reported feature of this trial.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome includes correlations across multiple EARNS-Q domains and multiple TSQM domains, as well as mean daily rTNSS. Examining several relationships raises a multiplicity question: when many statistical tests are conducted, the chance of at least one apparently notable result can increase. General explanation: investigators may address multiplicity through a prespecified hierarchy, adjustment, or by treating the analyses as exploratory. The method used for this study is not reported in the registry record. The number of planned tests and any distinction between confirmatory and exploratory analyses are also not reported.

The record describes an Intent-to-Treat population as all participants randomized to study drug. It does not report the number of participants with complete data for each measure, the amount or pattern of missing data, or how missing values were handled. It is not reported whether participants with incomplete period data were retained in some analyses, excluded from others, or included through an imputation method. These details matter because each correlation may have a different analysis sample.

The registry identifies Pearson correlations as the method for correlational analyses, but does not report additional adjustment, diagnostic checks, or sensitivity analyses. It also does not report the statistical analysis plan, whether the analysis methods were prespecified, or how deviations from any plan were handled. The record lists one analysis, but that does not establish that only one hypothesis or statistical test was conducted.

The sample-size illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are planning illustrations based on the observed effect, not an original trial justification or a measure of observed power. The original sample-size rationale is not reported in the registry record.

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 no serious adverse events in either treatment group: Beconase has 0 serious adverse events among 97 at risk, and Nasarel has 0 among 97 at risk. It also lists 0 deaths in each group. For other adverse events, the record lists 16 affected among 97 at risk for Beconase and 17 affected among 97 at risk for Nasarel. These are counts in the registry’s safety categories, not estimates of treatment effect.

The study is described as a crossover trial, so the treatment-group entries should not automatically be interpreted as two independent sets of participants. The registry record does not explain whether the same participants contributed to both treatment-group safety counts, how events were attributed across periods, or how the at-risk counts were defined. It also does not give event types for the other adverse events or the duration of exposure by treatment.

Zero reported serious events in these entries means none were recorded in the listed groups; it does not establish that serious events cannot occur. The record provides no comparative safety analysis or uncertainty estimates. These counts therefore describe the posted safety listings but do not support a broader conclusion about relative safety.

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

The trial’s stated purpose was to validate the EARNS-Q Preference Module and examine its reliability in relation to TSQM, with the primary outcome assessing correlations between preference scores and changes in satisfaction and nasal symptom scores. This is a measurement-focused question. It asks whether questionnaire scores align with other reported measures in the expected direction, rather than directly testing whether one nasal spray produces better clinical outcomes than another.

The study design and analysis description provide context for the intended question: a randomized, single-blind crossover study, with changes defined from Treatment Period 1 to Treatment Period 2 and Pearson correlations used for the correlational analyses. But the registry record does not report the primary correlation estimates, their confidence intervals, or p-values. It therefore does not show whether the expected associations were observed or how precisely they were estimated.

Even if numerical associations were available, correlation would not establish that preference caused a change in satisfaction or symptoms. Nor would an association alone establish that the questionnaire captures every relevant aspect of preference. General explanation: validation is usually supported by evidence across multiple properties and uses; one set of correlations can address only the relationships measured in that analysis.

The record lists secondary outcomes for mean rTNSS and preference between Nasarel and Beconase AQ, but their numerical results are not reported in the registry record. Safety listings include zero serious adverse events and zero deaths for each named group, along with other adverse event counts. Those figures are limited to the reported categories and should not be converted into a general treatment recommendation or a definitive comparative safety conclusion.

Thus, the record identifies an important statistical question about preference measurement but does not supply the numerical primary results needed to judge the evidence for the proposed relationships. It also does not report key details such as missing-data handling, multiplicity procedures, or how crossover effects were addressed. The study’s stated aim, design, and analysis approach can be described; the strength and precision of the findings cannot be determined from the posted registry information.

13. Why This Trial Matters Statistically

Preference questionnaires can capture aspects of treatment experience that symptom scores alone may not describe. The EARNS-Q includes an Experience Module and a Preference Module. The registry describes the Experience Module as containing 28 items, with attribute ratings followed by importance-weighting questions. The Preference Module includes those items, related preference questions, and a global preference question. This structure makes it statistically relevant to assess how preference scores relate to satisfaction and symptom measures, rather than treating the questionnaire as a single undifferentiated score.

The study also illustrates the distinction between measuring a construct and comparing treatments on an outcome. Its primary outcome is a set of correlations between preference scores and changes in TSQM and rTNSS. That approach addresses whether measures move together in expected ways. It does not directly answer whether treatment assignment caused a difference in symptoms, satisfaction, or preference.

The crossover design provides a setting in which participants receive successive treatments, potentially allowing within-participant comparisons. Such designs can be informative, but period, sequence, and carryover considerations may affect interpretation. The record identifies the design but does not report whether these features were incorporated in the analysis.

The statistical value of the study cannot be judged fully without the numerical correlation results and their precision. The record’s analysis description clarifies the intended estimands and sign conventions, but the missing coefficients, intervals, and p-values leave the central empirical findings unknown. Likewise, details about missing data and multiplicity are necessary for assessing how robustly the planned relationships were evaluated.

In this way, the registry entry is useful for understanding the measurement question and planned approach while also showing why outcome estimates and analytic detail matter. A clear research aim is not a substitute for posted results, and correlation methods require interpretation in the context of scale coding, crossover structure, and analysis choices.

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 most important limitation for interpreting this trial from the registry record is that numerical primary results are not reported. The record gives the correlation outcome and its intended interpretation, but no coefficients, confidence intervals, p-values, or analysis-specific participant counts. The magnitude, direction, and precision of the relationships therefore cannot be assessed.

The record does not report how missing measurements were handled, whether each randomized participant contributed to each analysis, or whether any imputation or sensitivity analysis was used. The stated Intent-to-Treat population definition does not answer those implementation questions. Details of multiplicity control are also not reported, despite the outcome involving several domains and relationships.

Although the study is described as a crossover, the record does not explain whether the analysis accounted for treatment sequence, period effects, or carryover. It does not give the treatment order, dose, detailed period schedule, or any washout information. Masking is described as single, but the masked parties are not identified. These omissions limit assessment of how the design was implemented and analyzed.

The population description is not fully consistent: the official title refers to adults with seasonal allergic rhinitis, while the condition entry says perennial allergic rhinitis. The record does not clarify this difference. It also does not report the number or locations of centers, which limits description of the recruitment setting.

Finally, the safety counts are not accompanied by event descriptions or a comparative analysis, and the crossover structure complicates interpretation of group counts without information on attribution and overlap. The registry record does not report the original sample-size justification or a full statistical analysis plan. These limitations concern the available record and do not establish that the underlying study lacked such procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) — NCT00346775.
• Registry record last updated 2018-01-16; status last verified 2017-12.
• Results first posted 2017-12-06.
• 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

NCT00346775 is recorded as a completed, randomized, single-blind, multicenter, Phase 3 crossover study with enrollment of 97. The official title describes a three-week study of adults with seasonal allergic rhinitis; the condition entry lists perennial allergic rhinitis. The interventions are beclomethasone dipropionate and flunisolide.

The stated aim was to validate the EARNS-Q Preference Module and examine reliability using TSQM. The primary outcome relates EARNS-Q preference scores to changes in TSQM domains and mean daily rTNSS from Treatment Period 1 to Treatment Period 2, over Day 1 to Day 23. Pearson correlations are specified for the Intent-to-Treat population.

Numerical primary correlation results, uncertainty estimates, and analysis-specific sample sizes are not reported in the registry record. Missing-data procedures, multiplicity methods, crossover adjustment details, and the original sample-size rationale are also not reported. The safety listing records no serious adverse events or deaths in either group and lists other adverse event counts of 16 for Beconase and 17 for Nasarel.