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 The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3) (NCT00423176), a randomized phase 3 study. The primary outcome is Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00423176 |
| Phase | Phase 3 |
| Condition | Sinusitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 237 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
People enrolled in a study of acute bacterial sinusitis. The registry lists an enrollment of 237, but notes that not every randomized participant had complete data and that the number analyzed does not match the participant-flow count.
Intervention
Mometasone furoate nasal spray (MFNS), used twice daily for 29 days alongside amoxicillin/clavulanic acid twice daily.
Comparator
Matching placebo nasal spray, used twice daily for 29 days, alongside amoxicillin/clavulanic acid twice daily.
Primary question
How did the average change from baseline in reflective AM/PM major symptom score, excluding sinus headache, compare between the nasal-spray groups over Days 1 to 29?
The study was designed to assess symptom relief and safety when nasal spray was added to antibiotic treatment. Its primary endpoint was based on patient ratings rather than an imaging measure. The registry summary also mentions computed tomography imaging of the sinuses as an objective measure, but a CT result is not reported in the registry record.
The comparison is an add-on-treatment question: both groups received amoxicillin/clavulanic acid, while the nasal spray differed. Thus, the comparison concerns the two assigned spray regimens in the context of antibiotic treatment, not nasal spray against no treatment. The registry record does not report enough outcome estimates to describe the size or precision of the between-group difference.
3. Trial Design
The record describes a randomized, double-masked, parallel-group phase 3 study sponsored by Organon and Co. The listed enrollment is 237. The study began in 2006-12, and primary completion is listed as 2008-06. Its status is terminated; the reason for termination is not reported in the registry record.
Participants were assigned to MFNS plus antibiotic or matching placebo nasal spray plus antibiotic. Both nasal sprays were used twice daily for 29 days. Both groups also received amoxicillin/clavulanic acid twice daily. This shared antibiotic treatment is important to interpreting the contrast: the groups differed in the assigned nasal spray, while the antibiotic component was common to both arm descriptions.
Random allocation is intended, in general, to reduce systematic differences between groups at the point of assignment. Double masking is intended, in general, to limit the influence of treatment knowledge on participants’ reports and on study conduct. These design features do not by themselves establish that all potential biases were prevented. Details about how allocation was generated, how masking was maintained, and whether masking was assessed are not reported in the registry record.
The registry describes a 29-day treatment period and a 2-week no-treatment follow-up period in the primary outcome timeframe. The specified primary measure averages the symptom-score change over Days 1 to 29, so the endpoint description focuses on the treatment period rather than giving a separate follow-up effect. Follow-up results are not reported in the registry record. The record lists the study as terminated, but the reason and any consequences for the planned analyses are not reported in the registry record.
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 (MFNS) | Placebo |
|---|---|---|
| STARTED | 114 | 123 |
| COMPLETED | 98 | 94 |
| NOT COMPLETED | 16 | 29 |
Reasons for not completing this period:
| Reason | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|
| Adverse Event | 4 | 6 |
| Treatment Failure | 1 | 6 |
| Lost to Follow-up | 4 | 7 |
| Withdrawal by Subject | 4 | 3 |
| Protocol Violation | 1 | 3 |
| Did not meet protocol eligibility | 2 | 4 |
Analysis population for the primary outcome, as defined in the registry: Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.
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 (MFNS) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 114 | 123 | 237 | |
| Age, Categorical: <=18 years | Participants | 5 | 6 | 11 |
| Age, Categorical: Between 18 and 65 years | Participants | 106 | 107 | 213 |
| Age, Categorical: >=65 years | Participants | 3 | 10 | 13 |
| Age, Continuous | years | 39.3 (SD 13.2) | 39.0 (SD 14.9) | 39.2 (SD 14.1) |
| Sex: Female, Male: Female | Participants | 80 | 72 | 152 |
| Sex: Female, Male: Male | Participants | 34 | 51 | 85 |
6. Primary Endpoint
The registry lists the primary outcome as Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29., measured over 29-day Treatment Period and 2-week no-treatment Follow-up Period..
| 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 least squares mean decrease from baseline in the reflective AM/PM major symptom score, excluding sinus headache, averaged over Days 1 to 29. The score reflects the participant’s assessment of symptom status over the previous 12 hours. The registry describes the score as covering facial pain, pressure or tenderness; sinus headache; purulent rhinorrhea; post-nasal drip; and nasal stuffiness or congestion. Each individual symptom is rated from 0, none, to 3, severe. For this endpoint, sinus headache is excluded from the score being analyzed.
A symptom score is useful for describing how participants experience illness, including features that may not be fully captured by an objective test. Averaging over the treatment period can represent the pattern of symptom change across multiple days rather than relying on a single assessment. In general, a decrease from baseline indicates a lower symptom score relative to baseline; it does not, on its own, establish how the groups compare.
The registry identifies the endpoint as a continuous measure reported using a mean and standard deviation. The least squares mean is an adjusted mean from a statistical model, but the model specification and the estimate itself are not reported in the registry record. No numerical between-group effect, confidence interval, or p-value for this endpoint is reported in the registry record. The registry’s mention of CT imaging does not establish an imaging result for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry entries establish the treatment contrast and define a patient-rated symptom endpoint, but they do not give a numerical estimate of the primary comparison. The record describes a decrease from baseline averaged over Days 1 to 29; it does not report the group-specific least squares means, the between-group contrast, its uncertainty, or a p-value. Consequently, the size and precision of any difference cannot be described from the registry record.
The phrase “least squares mean decrease” identifies a model-based summary, not a result in itself. To interpret the comparison, readers would need to know the estimated decrease in each group and the estimated difference between groups, along with an uncertainty measure such as a confidence interval. A confidence interval, in general, shows a range of values compatible with the data and model at the stated confidence level. The interval’s width conveys precision; the estimate alone does not.
The outcome’s direction also needs care. The endpoint is defined as a decrease from baseline in a symptom score, and lower symptom scores correspond to less severe ratings on the listed scale. But without the actual group estimates and the direction of the reported contrast, no conclusion about the comparative symptom pattern can be drawn. This is not a claim that the treatments were equivalent or that there was no difference. It is a statement that the needed comparative result is not reported in the registry record.
The record lists two outcome measures and three analyses, while indicating that the primary outcome has several categories or time points and is not reduced to one comparison. The number of analyses alone does not reveal which comparisons were prespecified, which were primary, or whether multiplicity was addressed. Those details are not reported in the registry record. The stated sample-size assumptions describe planning illustrations based on an observed effect, but the numerical planning outputs and the trial’s own design justification are not available in the registry record; they cannot substitute for outcome estimates or represent observed power.
The registry lists 237 participants enrolled and notes that incomplete data meant the analyzed count did not match the participant-flow count. That caveat matters because the analyzed group may not include every randomized participant. The number analyzed, reasons for missing data, and handling of missing observations are not reported in the registry record. Without those details, the potential effect of missing outcome data on the estimate cannot be evaluated.
9. Statistical Methods Explained
What does a least squares mean describe?
General explanation: a least squares mean is a model-based estimate of an average. It can account for variables included in the statistical model, so it need not equal the simple arithmetic average of the observed scores. The registry describes the endpoint as a least squares mean decrease, but the model, included variables, and estimation details are not reported in the registry record. The term therefore identifies the form of the endpoint summary without allowing readers to reproduce or assess the adjustment.
General explanation: a treatment comparison is most informative when it reports an estimated contrast between groups and its uncertainty. Group-specific averages can help readers understand the outcome in each arm, while a between-group contrast directly describes the estimated difference for the chosen analysis. The registry record does not report those primary-outcome estimates, so it is not possible to explain their magnitude or precision.
Why does the endpoint use a mean and standard deviation?
General explanation: a mean describes the central level of a continuous measurement, while a standard deviation describes how spread out individual measurements are around that mean. The registry categorizes the primary outcome as continuous and identifies the mean and standard deviation as its summary measures. No actual primary-outcome mean or standard deviation is reported in the registry record. A standard deviation is not the same as a standard error or a confidence interval: it describes variability among observations, whereas standard errors and confidence intervals describe uncertainty in an estimated quantity.
General explanation: a confidence interval can help distinguish a precise estimate from one that is uncertain. It should be read together with the estimated effect, the analysis population, and the assumptions of the model. Neither the primary-outcome confidence interval nor its p-value is reported in the registry record. Without these results, statistical significance and precision cannot be assessed from this record.
What is the role of randomization and masking?
General explanation: randomization is used to assign participants in a way intended to make treatment groups comparable, on average, with respect to both measured and unmeasured baseline characteristics. Masking is intended to reduce the chance that expectations or knowledge of assignment influence reports, care, or assessments. The registry identifies the study as randomized and double-masked. It does not report the sequence-generation procedure, allocation-concealment details, masking procedures, or assessment of masking, so those implementation features cannot be evaluated from the registry record.
The parallel-group design means participants were assigned to a treatment group rather than described as switching between the study sprays. Both arms included antibiotic therapy, and the assigned nasal spray differed. This design makes the intended comparison an addition of MFNS versus placebo spray alongside the antibiotic regimen described in the arm information. The record does not provide further detail about adherence or use of other treatments.
What does the planning approach mean?
General explanation: a sample-size planning illustration explores how many participants might be needed under specified assumptions about the effect to detect, the significance level, allocation, and statistical method. The registry’s stated assumptions use a two-sided significance level of 0.05, equal allocation, a normal approximation, and a fraction of the observed effect. For time-to-event outcomes, the stated convention is a total number of events; for other outcomes, it is participants per arm. The primary measure in this study is continuous, not time-to-event.
Such planning figures are illustrations, not observed results. They depend on assumptions, and the number of participants in an illustration should not be interpreted as proof that the trial had a particular probability of detecting its observed result. These figures are not “observed power.” The trial’s own sample-size justification and the actual numerical planning values are not reported in the registry record. No additional sample-size values can be inferred from the assumptions alone.
Why does over-dispersion matter in general?
General explanation: over-dispersion occurs when the observed variation in data exceeds what a chosen statistical model assumes. If a model does not allow for that extra variation, standard errors may be too small and uncertainty may appear narrower than it is. The registry identifies this endpoint as continuous and reports no over-dispersion assessment or model diagnostic. This concept is not a reported finding about this study; it is a general consideration when evaluating model assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and three analyses. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. These details signal that more than one outcome or analysis may be relevant to interpretation, but they do not identify the complete set of planned comparisons. The statistical plan, endpoint hierarchy, and any adjustment for multiple testing are not reported in the registry record.
Multiplicity matters in general because testing multiple hypotheses can increase the chance of finding an apparently notable result by chance. Methods for addressing it can include defining a hierarchy of outcomes or adjusting the threshold for inference, but the approach must be specified to interpret results. No such approach is reported in the registry record, and no numerical primary comparison is available to assess.
The record states that not every randomized participant had complete data and that the number analyzed does not match the participant-flow count. This is important because an analysis that excludes participants with incomplete measurements may differ from an analysis that handles missing observations under explicit assumptions. The number analyzed, missingness by group, reasons for missing data, and statistical method for handling missing data are not reported in the registry record.
The analysis population is also not described in enough detail to establish whether the primary analysis followed randomized assignment, used a subset, or applied another rule. The registry record does not report those definitions. These gaps limit assessment of whether the analysis preserved the intended randomized comparison and how robust the estimate might be to missing observations or analytic choices.
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 (MFNS) | 0 | 114 | 0.0% |
| Placebo | 1 | 123 | 0.8% |
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 (MFNS) | 22 of 114 |
| Placebo | 17 of 123 |
Most frequent serious adverse event terms
| Event term | Organ system | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|---|
| Neck Pain | Musculoskeletal and connective tissue disorders | 0 of 114 | 1 of 123 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Mometasone Furoate Nasal Spray (MFNS) | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 17 of 114 | 14 of 123 |
| Fungal Infection | Infections and infestations | 6 of 114 | 3 of 123 |
| Headache | Nervous system disorders | 6 of 114 | 1 of 123 |
Serious events with the highest arm-level rate: neck pain (0.8%).
The registry lists serious adverse events for 114 participants at risk in the MFNS group and 123 in the placebo group. It reports 0 serious adverse events in the MFNS group and 1 in the placebo group; the listed serious-event term is Neck Pain, with 0.8% shown. These are the registry’s recorded counts and term, not a basis for concluding that the groups had equivalent safety profiles.
The record also lists other adverse events affecting 22 of 114 participants at risk in the MFNS group and 17 of 123 in the placebo group. These figures are separate from the serious-event counts in the registry. The category definitions and detailed event listings are not reported in the registry record. No deaths are listed as reported values; death information is not reported in the registry record.
General explanation: adverse-event counts describe events recorded during a study and should be interpreted in light of the number of participants observed, the observation period, event definitions, and completeness of reporting. Rare events and differences between groups can be difficult to characterize with limited observations. These registry counts alone do not establish causation, exclude unrecorded events, or support a broad comparison of safety. Further details about ascertainment and the safety analysis are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of MFNS nasal spray plus antibiotic with placebo nasal spray plus antibiotic, and defines a patient-rated symptom endpoint averaged over Days 1 to 29. It also reports enrollment, study status, and selected adverse-event counts. These details explain the question the study set out to examine, but they do not provide the primary effect estimate needed to characterize the comparative symptom result.
The missing numerical outcome result should not be interpreted as evidence that the treatments performed the same way, nor as evidence of a difference. A conclusion about the estimated contrast requires the group results, a measure of uncertainty, and information about the analysis population and missing data. Those details are not reported in the registry record. The status “terminated” likewise does not explain why the study ended; a reason is not reported in the registry record.
The safety entries are descriptive. The counts of serious and other adverse events do not, on their own, establish whether events were caused by a study treatment or whether any broader safety difference exists. Their interpretation is constrained by the recorded denominators and the lack of further detail about event collection and analysis.
General explanation: a registry record is one source of trial information, and its usefulness depends on the completeness of the posted methods and results. Here, the endpoint definition and broad design are available, while the primary numerical comparison, uncertainty, analysis details, and explanation for termination are not reported in the registry record. The appropriate statistical reading is therefore limited to describing what is recorded and identifying the information needed for stronger conclusions.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why design details and outcome results serve different purposes. Randomization, masking, parallel-group assignment, and a clearly described symptom endpoint establish the intended structure of a comparison. They do not reveal the estimated effect or its precision. Without the numerical endpoint results, the central statistical question remains unanswered by the registry record.
The endpoint also illustrates the distinction between patient-reported outcomes and objective assessments. The primary measure is based on participants’ ratings of symptoms over the previous 12 hours and averaged across the treatment period. The study summary mentions CT imaging, but a CT result is not reported in the registry record. Different measurement approaches can answer related but distinct questions, and an outcome definition should be kept separate from an outcome result.
The incomplete-data note is another important statistical feature. A mismatch between the participant-flow count and the number analyzed indicates that the analysis did not include every randomized participant with complete data. Without the analysis population and missing-data method, readers cannot judge how that affected the comparison. Registry completeness is therefore part of statistical interpretation, not merely a reporting detail.
Finally, the record’s planning assumptions should not be confused with trial findings. Planning illustrations based on a fraction of an observed effect are conditional calculations, not observed power and not substitutes for the study’s actual effect estimate. This distinction helps keep design planning, analysis results, and interpretation separate.
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 principal limitation for interpreting efficacy is the absence of numerical primary-outcome results. The endpoint is defined, but group-specific estimates, the between-group contrast, uncertainty measures, and a p-value are not reported in the registry record. The record indicates that the primary outcome has several categories or time points and is not reduced to one comparison, further limiting a single-comparison interpretation.
The registry notes incomplete data and a mismatch between the number analyzed and the participant-flow count. It does not report the analyzed count, missingness by group, reasons for missingness, or the method used to handle missing observations. These omissions prevent assessment of possible selection effects or sensitivity to missing-data assumptions.
Other design and analysis details are also not reported in the registry record, including the allocation-generation method, detailed masking procedures, analysis population definitions, model specification, multiplicity approach, and the study’s own sample-size justification. The record gives a terminated status but does not report the reason. CT imaging is mentioned in the study summary, but CT results are not reported in the registry record.
The safety information is limited to the listed serious-event and other-event counts and one serious-event term. Further details about event definitions, collection, follow-up, and analysis are not reported in the registry record. These limits mean the available information supports a description of the study design and recorded safety entries, but not a full assessment of the primary treatment contrast or the broader safety profile.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3) — NCT00423176.
- Registry record last updated 2024-05-20; status last verified 2022-02.
- Results first posted 2010-06-22.
- 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.
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18. Record Summary
NCT00423176 is a randomized, double-masked, parallel-group phase 3 study of MFNS nasal spray plus antibiotic compared with placebo nasal spray plus antibiotic for acute bacterial sinusitis. The registry lists enrollment of 237, study start in 2006-12, primary completion in 2008-06, and status as terminated. The reason for termination is not reported in the registry record.
The primary endpoint is the least squares mean decrease from baseline in reflective AM/PM major symptom score, excluding sinus headache, averaged over Days 1 to 29. The endpoint is continuous and is described using a mean and standard deviation. The primary numerical comparison and its uncertainty are not reported in the registry record. The record notes incomplete data and a difference between the participant-flow count and the number analyzed.
Safety listings include 0 serious adverse events among 114 participants at risk in the MFNS group and 1 among 123 at risk in the placebo group. Other adverse events are listed for 22 of 114 and 17 of 123, respectively. Broader efficacy and safety interpretation is limited by the outcome and analysis details not reported in the registry record.