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 A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold (NCT01883453), a randomized phase 2 study. The primary outcome is Reducing Symptoms of a Common Cold.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01883453 |
| Phase | Phase 2 |
| Condition | Common Cold |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 146 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Umeå University |
| Results posted | Yes |
2. Clinical Question
Population
The study invited healthy persons to participate. For the primary outcome results, the record describes a narrower group: participants who completed the study and had a positive virus sample, excluding influenza and adenoviruses. The number of participants meeting those criteria is not reported in the registry record.
Intervention
The intervention was a nasal spray containing glucose oxidase and 5% glucose. Participants began treatment after taking a nasopharyngeal sample when they believed they had caught a common cold. The first treatment day involved 5 puffs in each nostril; treatment then continued three times daily for a total of one week.
Comparator
The comparator was a nasal spray containing isotone saline and 5% glucose. Its listed schedule was one puff in each nostril 5 times daily on the first treatment day, followed by three times daily for a total of one week. The record does not explain why the first-day schedules differ.
Primary question
The study asked whether the glucose oxidase and glucose spray could reduce common-cold symptoms, assessed using the Wisconsin Upper Respiratory Symptom Score (WURSS-21) over one week. The registry record does not report the symptom-score values or an analysis comparing the groups.
3. Trial Design
This was a phase 2, randomized, quadruple-masked, parallel-group study sponsored by Umeå University. The registry lists enrollment of 146 participants and describes the study as completed. The recorded study dates are 2013-01 for the start and 2013-05 for primary completion. These details describe the registered design and status; they do not establish how many participants contributed to the primary outcome.
Participants were given a home protocol using WURSS-21, a nasal spray, and a sample pin. They were instructed to take a nasopharyngeal sample when they were sure they had caught a common cold, then begin spraying and complete daily records. This approach ties treatment initiation and symptom recording to the onset of a suspected episode. The record does not state how the onset decision was verified or how adherence to sampling, treatment, and daily reporting was assessed.
The two arms used sprays with a shared 5% glucose component but different active ingredients: glucose oxidase in the intervention spray and isotone saline in the comparator. Their listed first-day schedules also differed. The record does not report the allocation ratio, the method used to generate or conceal the randomization sequence, or which roles were masked. It identifies masking as quadruple but does not specify the four roles.
The primary outcome is described as symptom reduction measured with WURSS-21 over one week. The analysis population was limited to participants who completed the study and had a positive virus sample, with influenza and adenoviruses excluded. The number in that population and the flow from enrollment to analysis are not reported in the registry record. Although one outcome measure is listed, the registry reports 0 analyses and does not provide a single reduced comparison.
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 | Saline+Glucose Nasal Spray | Nasal Spray With Glucose Oxidase+Glucose |
|---|---|---|
| STARTED | 73 | 73 |
| COMPLETED | 48 | 50 |
| NOT COMPLETED | 25 | 23 |
Reasons for not completing this period:
| Reason | Saline+Glucose Nasal Spray | Nasal Spray With Glucose Oxidase+Glucose |
|---|---|---|
| No episode of common cold | 25 | 23 |
Analysis population for the primary outcome, as defined in the registry: Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.
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.
Population: Healthy adult volunteers. One part of the included participants was from an education in elite skiing at the University and one part was from a military unit. The participants were told to start the treatment as soon as they were convinced that they had caught a common cold
| Characteristic | Unit | Saline+Glucose Nasal Spray | Nasal Spray With Glucose Oxidase+Glucose | Total |
|---|---|---|---|---|
| Participants analysed | 48 | 50 | 98 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 47 | 48 | 95 |
| Age, Categorical: >=65 years | Participants | 1 | 2 | 3 |
| Age, Continuous | years | 38 (19 to 72) | 40 (18 to 70) | 39 (18 to 72) |
| Sex: Female, Male: Female | Participants | 30 | 28 | 58 |
| Sex: Female, Male: Male | Participants | 18 | 22 | 40 |
| Region of Enrollment: Sweden | participants | 48 | 50 | 98 |
6. Primary Endpoint
The registry lists the primary outcome as Reducing Symptoms of a Common Cold, measured over One week.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary outcome concerns common-cold symptoms measured with the Wisconsin Upper Respiratory Symptom Score, WURSS-21. The record describes 21 questions, of which 20 can be evaluated, with each evaluated question graded from 0 to 7. The sum of those 20 symptom questions can range from 0 to 140 per person per day. The record says that the mean symptom sum for each day could be calculated for both groups.
A symptom score offers a structured way to capture how participants experience an illness, rather than relying only on a laboratory result. The registry describes WURSS-21 as a validated tool for calculating the degree of common-cold symptoms. Daily recording is relevant to the stated aim of shortening an episode because symptoms are followed over the treatment period, although the record does not define an episode-ending criterion or report episode duration results.
The listed timeframe is one week. The description refers to mean symptom scores for each day, but no daily values, group summaries, uncertainty estimates, or statistical comparison are reported in the registry record. The record therefore establishes what was intended to be measured, not what symptom pattern or difference was observed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the study question and the intended symptom measure, but it does not give the numerical primary outcome results. It reports no group means, daily symptom values, estimated difference, confidence interval, or p-value. Consequently, the size and precision of any difference between the glucose oxidase spray and the saline spray cannot be assessed from the registry record.
The record lists one outcome measure and 0 analyses. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. That matters because the outcome description includes daily symptom means across a one-week timeframe. Without a specified single comparison or the corresponding results, a reader cannot determine which day, summary across days, or other outcome contrast—if any—was used to assess the study question.
The listed enrollment is 146, but the population included in the primary outcome results was restricted to participants who completed the study and had a positive virus sample, excluding influenza and adenoviruses. The size and characteristics of that outcome population are not reported in the registry record. Enrollment alone should not be treated as the number analyzed, and the record does not permit reconstruction of participant flow or the proportion with qualifying samples.
The registry’s outcome description says that WURSS-21 scores can be used to calculate daily mean symptom sums in both groups. That is a description of a possible summary, not evidence that these summaries were posted or that a particular statistical analysis was conducted. The record does not report whether the groups differed, whether uncertainty was estimated, or how repeated daily observations were handled.
Accordingly, the appropriate statistical reading is limited: a randomized trial was registered to evaluate a symptom outcome over one week, but the posted registry record does not contain enough outcome information to quantify an effect. This absence is not evidence that the sprays had equal results, nor is it evidence of a benefit or harm. It means that the comparison is not interpretable from the outcome information in this record.
9. Statistical Methods Explained
What does randomization contribute?
Randomization assigns participants to study arms by chance. In general, this is intended to make the groups comparable with respect to factors that could influence an outcome, including factors that are not measured. It supports a fair comparison when the assignment process is implemented as intended and when participants are analyzed in a way that preserves the randomized comparison. The registry identifies the study as randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record. The record also does not report an analysis population defined by original assignment or explain how participants with missing outcomes were handled.
What does masking mean in this record?
The masking field is quadruple. In general, masking can reduce the chance that knowledge of treatment assignment affects participant expectations, treatment delivery, outcome assessment, or analysis decisions. The registry does not identify which roles were masked or explain how masking was maintained. The record’s label therefore describes the stated masking level but does not allow a reader to evaluate those implementation details. Because the primary outcome is based on participant symptom reports, the conduct of masking is a relevant design detail, but its success cannot be assessed from the registry record.
How should the symptom scale be understood?
WURSS-21 is described as a validated symptom instrument with 21 questions, 20 of which can be evaluated. Each evaluated question is graded from 0 to 7, and the symptom items are summed for a daily score with a possible range from 0 to 140 per person per day. In general, a scale turns reported experiences into a structured measure that can be summarized and compared. A score is not the same as a diagnosis, and a group mean does not show every participant’s experience. The registry does not report the actual score distributions or daily group means.
Why does the timing of measurement matter?
The study aimed to start treatment at the onset of an episode and collect daily records. Repeated daily measurements can describe how symptoms change during follow-up, but they also create choices about what comparison best answers the question. An analysis might focus on a particular day, a summary across days, or a trajectory over time; these approaches answer related but not identical questions. The registry record does not report which summary or model was used. It explicitly notes that the outcome has several categories or time points and was not reduced to one comparison, so no single effect estimate can be interpreted from the record.
What can a confidence interval tell a reader?
In general, a confidence interval expresses the uncertainty around an estimated effect under the assumptions of the statistical method. Its width reflects the precision of that estimate; an interval that is wide allows a broader range of effects than a narrow interval. An interval must be interpreted alongside the outcome definition and analysis population. No confidence interval or effect estimate is reported for this trial’s primary outcome, so neither the estimated direction nor its precision can be described.
What is the role of a p-value?
In general, a p-value measures how incompatible data are with a specified statistical null model, given the assumptions of the test. It does not measure the probability that a treatment works, nor does it describe the magnitude or clinical importance of an effect. A p-value is most informative alongside an effect estimate, its uncertainty, and the analysis plan. The registry record reports no primary-outcome p-value and no analysis reduced to one comparison. No conclusion about statistical significance can therefore be drawn from this record.
Why do analysis populations and missing data matter?
In general, excluding participants after randomization can affect how comparable the groups remain, particularly when exclusions are related to illness, treatment, or outcome. Missing daily records can also affect summaries of repeated measurements. Here, the stated outcome population includes participants who completed the study and had a positive virus sample, excluding influenza and adenoviruses. The number meeting those criteria, reasons for noncompletion, and handling of missing daily scores are not reported in the registry record. The impact of those choices cannot be evaluated.
What does the record allow statistically?
The registry gives the design, planned measure, timeframe, and a description of the selected outcome population. It does not give outcome values or inferential results. Statistical methods can explain what would be needed to interpret a comparison, but they cannot recover an effect from a description of the measurement alone. The primary outcome’s direction, magnitude, and precision are therefore not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description refers to daily mean symptom sums over one week. This creates multiple potential time points for describing or comparing symptoms. In general, when several outcomes or time points are examined, the chance of finding an apparently notable result by chance can increase if the analysis does not account for the number of comparisons. A prespecified primary contrast and a transparent analysis plan help readers understand which result is central and how additional comparisons were handled.
The registry record does not report a statistical analysis plan, a designated single day or summary comparison, or any multiplicity procedure. It states that the primary outcome has several categories or time points and was not reduced to one comparison. The record lists 0 analyses. It is therefore not possible to determine how many comparisons were conducted, whether adjustments were used, or how the reported outcome—if analyzed outside the registry—was selected.
The outcome population is described as participants who completed the study and had a positive virus sample, excluding influenza and adenoviruses. The number in that population is not reported in the registry record. Reasons for not completing the study, sample failures, missing daily reports, and methods for handling missing observations are also not reported. In general, missingness can affect an estimate when the likelihood of missing data is connected to symptoms, treatment, or other participant characteristics. The record does not provide enough information to assess whether that concern applies.
The registry also does not report an intention-to-treat analysis, a per-protocol analysis, or another named analysis population. The population description indicates who was included in the results, but the record does not give the count or explain how that selection was implemented. These omissions limit assessment of both the analysis population and the reliability of any unposted comparison.
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 |
|---|---|---|---|
| Saline+Glucose Nasal Spray | 0 | 48 | 0.0% |
| Nasal Spray With Glucose Oxidase+Glucose | 0 | 50 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Saline+Glucose Nasal Spray | 0 of 48 |
| Nasal Spray With Glucose Oxidase+Glucose | 0 of 50 |
The registry reports serious adverse events in 0 of 48 participants at risk in the saline-plus-glucose arm and 0 of 50 participants at risk in the glucose-oxidase-plus-glucose arm. It also reports other adverse events in 0 of 48 and 0 of 50 participants, respectively. These figures describe the adverse-event entries in the registry; they do not provide details about event definitions, collection methods, or the observation period for safety reporting.
The deaths field is null for both groups. A null entry is not the same as a reported count of 0, so deaths are not reported in the registry record. The list of leading serious adverse-event terms is empty. This indicates that no terms are listed there, not that every possible safety event was ruled out.
In general, event counts should be interpreted with their population, follow-up, and ascertainment methods in mind. These safety figures do not establish that an intervention is safe or unsafe, and they do not describe symptoms that may not have been classified as adverse events. The registry record does not report enough detail to evaluate completeness of safety monitoring or compare risks beyond the recorded counts.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group phase 2 study was registered to investigate whether a nasal spray containing glucose oxidase and glucose could reduce common-cold symptoms. It describes home sampling, treatment initiation when participants believed a cold had begun, daily symptom recording, a one-week timeframe, and WURSS-21 as the measure. These details clarify the research question and intended measurement approach.
The record does not establish what the primary outcome showed. It contains no daily symptom values, group means, estimated treatment contrast, confidence interval, or p-value. The listed enrollment of 146 does not identify the number contributing to the outcome because the analysis population was limited to participants who completed the study and had a qualifying positive virus sample. The count in that selected population is not reported in the registry record.
This absence of outcome results should not be interpreted as evidence of no difference, a difference, or a particular direction of effect. It also does not show that the intervention did or did not shorten a cold. The stated aim is not itself a result. The registry record reports one outcome measure but 0 analyses, and it notes that the outcome’s several categories or time points were not reduced to one comparison.
The safety entries report 0 serious and 0 other adverse events in the listed at-risk groups. Deaths are not reported in the registry record. These entries provide limited recorded counts, not a complete assessment of safety. Overall, the available record supports a description of the trial’s design and planned symptom outcome, but it does not support a statistical conclusion about the comparative symptom effect or its precision.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a registered research question and interpretable outcome evidence. The record describes randomization, masking, a comparator, a symptom instrument, and a one-week follow-up. Those elements help readers understand how the study was intended to compare two nasal sprays. Yet a design description cannot substitute for observed group results.
The choice to collect symptoms daily is relevant to an illness that changes over time. Repeated scores can capture the course of symptoms more fully than a single measurement, but they also require clear choices about the primary time point or summary and how repeated observations are analyzed. The registry record notes several categories or time points but does not reduce them to one comparison. This makes the absence of a prespecified, reported contrast especially important for interpretation.
The record also defines a selected outcome population based on study completion and a positive virus sample, with influenza and adenoviruses excluded. That eligibility description affects what the result would represent: not necessarily every person enrolled or every person with a suspected cold. Because the size of this group is not reported, readers cannot assess how much of the enrolled population the outcome results would cover.
Finally, the sparse outcome reporting illustrates why estimates and uncertainty are essential. Without a numerical effect and an interval or other uncertainty measure, statistical precision cannot be judged. The registry is useful for identifying the intended design and the limits of the posted information, but it does not permit a quantitative conclusion about the primary question.
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 central limitation for interpreting this specific trial is that the registry record does not report the primary symptom outcomes. It gives no daily WURSS-21 values, group means, treatment-effect estimate, uncertainty interval, or p-value. Although the outcome is described over one week and as a daily mean symptom sum, the record does not state which time point or summary would provide the main comparison. It notes that the outcome has several categories or time points and was not reduced to one comparison.
The registry describes the analysis population as participants who completed the study and had a positive virus sample, excluding influenza and adenoviruses, but does not report how many participants met those criteria. It also does not provide participant flow, reasons for noncompletion, sample results by arm, or the number of missing daily symptom records. As a result, the relationship between enrollment and the population contributing outcome data cannot be evaluated.
Some design and conduct details are also not reported in the registry record. These include the allocation ratio, random-sequence method, allocation concealment, the roles covered by quadruple masking, adherence to the spray schedules, and the statistical analysis plan. The record does not explain the rationale for the different first-day dosing schedules. These omissions make it harder to assess implementation and the basis for analysis choices.
Safety reporting is limited to the posted adverse-event counts and does not include event definitions or detailed monitoring information. The deaths entries are null rather than reported zero counts. Taken together, these limitations mean that the registry record supports a description of the trial design, but not an evaluation of the primary comparative outcome or a comprehensive appraisal of trial conduct.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold — NCT01883453.
- Registry record last updated 2015-11-09; status last verified 2015-06.
- Results first posted 2015-11-09.
- 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
The registry describes a completed, randomized, quadruple-masked, parallel-group phase 2 study sponsored by Umeå University, with enrollment of 146. It compared a glucose oxidase plus 5% glucose nasal spray with an isotone saline plus 5% glucose nasal spray. Participants were asked to sample when they believed a cold had begun, start treatment, and record symptoms daily. The primary outcome was WURSS-21 symptom scoring over one week, with results restricted to participants who completed the study and had a positive virus sample, excluding influenza and adenoviruses.
The registry record reports one outcome measure and 0 analyses. It does not report primary symptom values or a single comparison. Serious and other adverse-event counts are recorded as 0 in both arms; deaths are not reported in the registry record. The information supports a description of the planned question and design but does not establish the comparative symptom effect.