This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma (NCT00599027), a randomized phase 3 study. The primary outcome is The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00599027 |
| Phase | Phase 3 |
| Condition | Allergic Rhinitis, Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 51 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
People with moderate to severe persistent allergic rhinitis and intermittent asthma. The registry record lists allergic rhinitis and asthma as the conditions studied and reports enrollment of 51 participants.
Intervention
Mometasone furoate nasal spray, also called MFNS in the record, at 200 mcg once daily in the morning, given as two 50 mcg puffs per nostril.
Comparator
Placebo nasal spray once daily in the morning, given as two puffs per nostril.
Primary question
Whether the change in the Rhinasthma Global Summary Score from baseline to endpoint after 28 days of treatment differed between mometasone furoate nasal spray and placebo.
The study’s primary objective was to explore whether mometasone furoate nasal spray could improve quality of life in participants with both conditions, as measured by the Rhinasthma Questionnaire. A secondary objective was to evaluate allergic-rhinitis and asthma symptoms. The registry record identifies the comparison and the outcome instrument, but it does not report a numerical treatment contrast, its uncertainty, or a statistical test result for the primary outcome. It also does not identify a single category or time-point comparison to use as the definitive answer to the primary question.
The question is therefore clear as a study objective, but the posted results do not establish the size or precision of any difference between groups. The record supports describing the study’s population, treatments, and intended outcome; it does not support a conclusion about the direction or magnitude of the quality-of-life result.
3. Trial Design
This was a randomized, triple-masked, parallel-group Phase 3 study. The record lists enrollment of 51 and describes two arms: mometasone furoate nasal spray and placebo nasal spray. In a parallel-group design, participants are assigned to one study arm and the outcomes in the groups are compared. Random allocation is intended to make the groups comparable on average at the point of assignment, although it cannot guarantee balance in a study of any particular size.
The active treatment was mometasone furoate nasal spray at 200 mcg once daily in the morning, delivered as two 50 mcg puffs per nostril. The placebo arm used placebo nasal spray once daily in the morning, with two puffs per nostril. The record describes the masking as triple, but does not identify which roles were masked or provide further details about how masking was maintained. Further details of the randomization procedure, allocation concealment, and treatment adherence are not reported in the registry record.
The study start is recorded as 2008-05, and primary completion as 2009-05. The status is completed. The sponsor is Organon and Co. The record gives the primary outcome timeframe as baseline and 28 days of treatment, and the stated outcome is the change in the Rhinasthma Global Summary Score.
Enrollment and arm counts describe the number of participants at risk in the posted safety results; they do not by themselves establish how many participants contributed data to the primary outcome analysis. The analysis population, participant flow, withdrawals, and outcome-specific denominators are not reported in the registry record. Nor is the planned sample-size justification reported. The trial’s design features can be described, but the available record does not provide enough detail to reconstruct its full conduct or primary analysis.
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
| Stage | Mometasone Furoate Nasal Spray | Placebo Nasal Spray |
|---|---|---|
| STARTED | 26 | 25 |
| COMPLETED | 25 | 22 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | Mometasone Furoate Nasal Spray | Placebo Nasal Spray |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Adverse Event | 0 | 1 |
| Treatment Failure | 0 | 1 |
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.
| Characteristic | Unit | Mometasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|---|
| Participants analysed | 26 | 25 | 51 | |
| Age, Continuous | years | 40.5 (SD 13.42) | 43.0 (SD 16.62) | 41.7 (SD 14.97) |
| Sex: Female, Male: Female | Participants | 11 | 12 | 23 |
| Sex: Female, Male: Male | Participants | 15 | 13 | 28 |
6. Primary Endpoint
The registry lists the primary outcome as The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment., measured over Baseline and 28 days of treatment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the change in the Rhinasthma Global Summary Score from baseline to endpoint after 28 days of treatment. The questionnaire has 30 items. For each item, participants indicate on a Likert scale from 1, not at all, to 5, very much, the degree of limitation or discomfort caused by the problem. The record describes a possible total best score of 150 and possible total worst score of 30.
The score is intended to capture quality of life related to allergic rhinitis and intermittent asthma, rather than only a single symptom. A change from baseline uses each participant’s starting score as a reference, which can make the comparison more informative than looking only at endpoint values when participants begin with different scores. Interpreting the direction and size of a change requires the scoring convention and the actual results; the record describes the scale’s best and worst possible totals but does not provide a numerical group comparison.
The registry record identifies the outcome as a mean with standard deviation, but does not report the means, standard deviations, or a treatment-effect estimate for a single comparison. The clinical importance of a particular score change is not reported in the registry record. Consequently, the endpoint’s intended measurement can be explained, but its observed effect and its practical meaning cannot be determined from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of mometasone furoate nasal spray with placebo and identifies change in the Rhinasthma Global Summary Score as the primary outcome. However, it does not report a single numerical comparison for that outcome. The primary outcome is flagged as having several categories or time points and is not reduced to one comparison. No group means, standard deviations, treatment contrast, confidence interval, or p-value for a single primary comparison are reported in the registry record.
This absence limits interpretation. Without a treatment contrast, readers cannot tell from the posted results how far apart the groups were on the outcome. Without a confidence interval, they cannot judge the range of effects compatible with the data or how precisely an effect was estimated. Without a test result, the record does not convey the evidence against a no-difference hypothesis for a defined comparison. These gaps do not imply that the groups were identical; they mean that a single primary estimate cannot be evaluated from the information reported.
The score is a multi-item quality-of-life measure, and the stated measurement period is baseline and 28 days of treatment. Those details describe what the outcome was intended to capture and when it was assessed. They do not substitute for results. The stated primary objective was exploratory, but that label alone does not specify how an analysis was conducted or how uncertain its findings are.
The study enrolled 51 participants, while the posted safety groups list 26 participants at risk in the mometasone group and 25 in the placebo group. Those counts are safety denominators and should not be assumed to be the numbers analyzed for the primary endpoint. Primary-outcome denominators and analysis-population definitions are not reported in the registry record.
The registry record lists zero serious adverse events and zero other adverse events in each arm among the participants at risk for those outcomes. These are event counts as recorded, not a complete description of all possible harms or a guarantee that no events occurred outside the reported categories or observation period. Overall, the record permits a description of the trial question, design, endpoint, and posted adverse-event counts. It does not support a quantitative conclusion about the primary treatment effect or its precision.
9. Statistical Methods Explained
What does a mean represent?
General: A mean is the arithmetic average of measured values in a group. For a continuous outcome such as a questionnaire score, it gives a compact description of the group’s central value. A mean alone does not show how much participants differ from one another. The registry record identifies the primary outcome as a mean and its dispersion measure as a standard deviation, but does not post the values needed to examine either summary for a single comparison.
General: A standard deviation describes the spread of individual measurements around the mean. It is not the same as a standard error or a confidence interval: the standard deviation concerns variation among observations, whereas a confidence interval describes uncertainty in an estimated quantity. No confidence interval for the primary treatment contrast is reported in the registry record, so the precision of that contrast cannot be assessed from the record.
Why compare change from baseline?
General: A change score is calculated by comparing a participant’s measurement at a later assessment with their baseline measurement. Comparing change between randomized groups can help account for differences in starting scores. It is important to know exactly which time points and which score summaries were analyzed, because different choices can answer different statistical questions. The record states that the endpoint concerns change from baseline to endpoint after 28 days, but it does not report a single corresponding group contrast.
What does randomization contribute?
General: Random assignment is designed to distribute both known and unknown participant characteristics across study groups without systematic selection by investigators. This supports a causal comparison when treatment assignment, follow-up, outcome measurement, and analysis are handled appropriately. Randomization does not ensure that groups will be identical, and it does not remove uncertainty, particularly in a study with limited enrollment. The record identifies the study as randomized but does not describe the sequence-generation method, allocation concealment, or balance of baseline characteristics.
How should a confidence interval be read?
General: A confidence interval gives a range of values compatible with the observed data under the analysis assumptions. Its width communicates precision: a narrower interval indicates more precise estimation, while a wider interval indicates greater uncertainty. A confidence interval also helps readers distinguish an estimate’s direction from the uncertainty around it. Because the registry record does not report a single primary comparison or its interval, neither the estimated direction nor its precision can be evaluated for that comparison.
What would a p-value answer?
General: A p-value measures how incompatible the observed data are with a specified null hypothesis, under the model used for the analysis. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. A p-value needs to be interpreted alongside the effect estimate, its uncertainty, the analysis plan, and the number of comparisons. A single primary p-value is not reported in the registry record.
Why can multiplicity matter?
General: When several outcomes, time points, or subgroups are examined, the chance of obtaining at least one apparently unusual result can increase if each is tested separately without accounting for the collection of tests. A prespecified hierarchy or other multiplicity approach can help define which finding is confirmatory and how the error rate is controlled. The registry record notes that the primary outcome has several categories or time points and is not reduced to one comparison. A multiplicity strategy is not reported in the registry record.
What do planning assumptions mean?
General: A sample-size illustration based on an observed effect is a planning exercise, not a measure of power achieved by the completed trial. The record describes planning assumptions of a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a fraction of the observed effect. Such assumptions can help illustrate how a hypothetical future study might be sized, but they do not establish the trial’s own design rationale or turn an observed result into evidence of adequate power. The trial’s original sample-size justification is not reported in the registry record.
For continuous outcomes, over-dispersion means that variability is greater than an analysis model expects. General: If a model understates variability, uncertainty can be understated and statistical conclusions can become too confident. The posted outcome description uses a mean and standard deviation; it does not report a model, a dispersion assessment, or an adjustment for over-dispersion. No claim about such an adjustment can therefore be made.
The record does not state whether the primary analysis adjusted for baseline score or other characteristics, how missing observations were handled, or whether the analysis followed intention-to-treat principles. These choices can affect the estimate and its interpretation. Without the analysis details and a defined numerical comparison, a recalculation from summary statistics is not available. The registry record’s own analysis cannot be assessed or reproduced from the reported endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is described as having several categories or time points and is not reduced in the registry record to one comparison. That matters because a collection of outcome contrasts can raise questions about which comparison was primary and how the risk of false-positive findings was handled. The record does not report a multiplicity procedure, a testing hierarchy, or which of the categories or time points was designated as the main contrast for statistical inference. It is therefore not possible to identify a single result as the definitive primary test from the posted information.
Details about missing outcome data are also not reported in the registry record. The record does not state how many participants completed the Rhinasthma questionnaire, whether any scores were missing, why data might have been missing, or how missing values were handled. It does not describe imputation, complete-case analysis, or sensitivity analyses. These are material details because missingness can affect both the available sample and the interpretation of a group comparison.
The analysis population is not reported in the registry record. In particular, the record does not say whether the primary analysis included all randomized participants, only participants who completed treatment, or another defined group. The safety denominators should not be treated as primary-outcome denominators. The statistical analysis plan, adjustment strategy, and handling of protocol deviations are likewise not reported in the registry record. Without these details, neither the analysis population nor the robustness of a primary-outcome estimate can be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | 0 | 26 | 0.0% |
| Placebo Nasal Spray | 0 | 25 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Mometasone Furoate Nasal Spray | 0 of 26 |
| Placebo Nasal Spray | 0 of 25 |
The posted safety results list 26 participants at risk in the mometasone furoate nasal spray group and 25 in the placebo nasal spray group. Serious adverse events are recorded as 0 in each group. Other adverse events are also recorded as 0 in each group. These are counts within the categories and denominators stated in the record; they are not estimates of comparative risk or proof that the treatments have no safety concerns.
The record does not give a safety observation timeframe, definitions of the event categories, or a detailed listing of non-serious events. Death counts are not reported in the registry record. The number of participants at risk for the safety outcomes should not be assumed to equal the number contributing data to the primary quality-of-life analysis.
General: Zero recorded events in a study group means that no events in that defined category were entered for the stated group in the posted results. It does not establish that the underlying event rate is zero, especially when the number of participants is limited. The available counts therefore describe what the registry record reports, but do not permit a comprehensive safety comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to explore a comparison between mometasone furoate nasal spray and placebo for quality of life among participants with moderate to severe persistent allergic rhinitis and intermittent asthma. It identifies the Rhinasthma Global Summary Score, its baseline-to-endpoint change, and a treatment period of 28 days. It also describes a randomized, triple-masked, parallel-group design and reports enrollment of 51 participants.
Those details describe the question and structure of the trial, not its numerical answer. The record does not report one primary outcome comparison with an effect estimate and uncertainty. As a result, it does not establish the magnitude or direction of a difference in Rhinasthma scores, how precisely such a difference was estimated, or whether a statistical test supported a particular conclusion. Absence of a single reported comparison should not be interpreted as evidence that there was no difference.
The record also does not state a threshold for a clinically important score change. Even if a numerical contrast were available, readers would need context about the scale and the importance of the observed change to interpret its practical relevance. The questionnaire’s possible score range and item format explain how the outcome is structured, but do not by themselves identify what size of change matters to participants.
The posted adverse-event counts report no serious or other adverse events in either group among those at risk as listed. That finding is limited to the categories and information recorded; it does not establish the absence of all harms. Overall, the registry entry supports a careful account of the study’s methods and reported safety counts, but not a claim that either treatment did or did not improve quality of life.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a well-defined research question and a fully interpretable result. The record identifies the population, randomized comparison, masking, treatment schedules, and a patient-reported quality-of-life measure. Those details let readers understand what the investigators intended to study. Yet the primary outcome is not reduced to a single numerical comparison, leaving the main treatment-effect question unanswered by the posted results.
That distinction matters in clinical research. A study can have an identifiable primary objective and a specified outcome instrument while still providing too little outcome information for readers to assess effect size and precision. Statistical interpretation depends not only on whether a study was randomized or masked, but also on the actual estimate, uncertainty, analysis population, missing-data handling, and the relationship between planned comparisons and reported results.
The score also combines responses across 30 questionnaire items. Such a measure can capture a broader experience than a single symptom, but the resulting mean needs to be interpreted with a clear scoring description and a defined comparison. The record gives scale details and a measurement timeframe, but it does not supply the single contrast needed to evaluate the outcome quantitatively.
The safety counts illustrate another statistical point: zero observed events in a group is a statement about the posted count, not proof that the event cannot occur. Counts need denominators, event definitions, and a period of observation to support meaningful interpretation. Here, the record gives group denominators but lacks further safety details. Together, these features make the entry useful for understanding study design and reporting limitations, while underscoring why a complete estimate and analysis context are essential for drawing statistical conclusions.
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 interpretation is that the registry record does not report a single numerical comparison for the primary endpoint. It identifies the outcome as a mean with standard deviation, but provides no group summaries or treatment-effect estimate for one defined contrast. The record notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, the principal result cannot be evaluated for direction, magnitude, or precision.
Several details needed to assess the analysis are not reported in the registry record: the primary analysis population, outcome-specific denominators, missing-data handling, baseline adjustment, and the statistical analysis plan. The record also does not explain the randomization procedure, allocation concealment, treatment adherence, or which roles were masked. These omissions limit assessment of potential bias and reproducibility.
The registry entry describes the questionnaire’s score structure but does not report a threshold for a clinically important change. It also does not provide the timing or definitions for adverse-event reporting, and deaths are not reported in the registry record. The safety counts therefore have limited interpretive scope.
The record describes the primary objective as exploratory and lists a Phase 3 study with enrollment of 51 participants. It does not report a sample-size justification for the trial. Without the primary estimate and its uncertainty, the available information cannot show whether the study’s enrollment was adequate for a particular effect or whether a reported finding would be robust. These limitations concern what can be concluded from the registry record; they do not establish what the full study report may contain.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma — NCT00599027.
- Registry record last updated 2024-05-21; status last verified 2022-02.
- Results first posted 2010-04-30.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The completed Phase 3 study, sponsored by Organon and Co, compared mometasone furoate nasal spray with placebo in participants with moderate to severe persistent allergic rhinitis and intermittent asthma. It was randomized, triple-masked, and parallel-group, with enrollment of 51. The active arm used mometasone furoate nasal spray at 200 mcg once daily in the morning; the placebo arm used placebo nasal spray once daily.
The primary outcome was change in the Rhinasthma Global Summary Score from baseline to endpoint after 28 days of treatment. The record describes a 30-item questionnaire and its possible score range, but does not report a single numerical primary comparison. The analysis population, missing-data approach, and multiplicity strategy are not reported in the registry record.
Posted safety results list zero serious and zero other adverse events in each group, with 26 and 25 participants at risk, respectively. Death counts are not reported in the registry record.