Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis (NCT01550471), a randomized phase 4 study. The primary outcome is The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis..

2. Clinical Question

3. Trial Design

This was a randomized, unmasked, Phase 4 crossover study of pediatric subjects with mild asthma and allergic rhinitis. The registry records enrollment of 22 and a completed study sponsored by West Penn Allegheny Health System. The recorded start is 2012-03, and primary completion is listed as 2015-08. These dates describe the registry record and do not add detail about the conduct of individual visits.

The design assigned participants to treatment sequences rather than to a single treatment arm for the entire study. The six listed sequences varied the order of the Omnaris-and-Alvesco combination, the Beconase-and-QVAR combination, and placebo nasal spray with placebo inhalation aerosol. Each sequence lists these conditions in periods identified as Period 2, Period 4, and Period 6. The registry does not report the length of each period, the timing of transitions, or whether washout intervals were used.

The brief study description says subjects would be seen weekly for 18 weeks and that lower-leg length would be measured at each visit using knemometry. The primary outcome timeframe is recorded as 1 yr. How that timeframe relates to the described weekly visits is not reported in the registry record. The record also does not specify the planned statistical model for handling repeated measurements or the crossover structure.

Because each participant could receive multiple conditions in sequence, a crossover design can, in general, compare conditions within the same person. Such comparisons can account for stable differences between participants, but depend on appropriate handling of period effects, sequence, and possible carryover. The registry does not report how those issues were addressed. Masking is listed as none, so the record does not describe blinding of participants or study personnel.

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.

Run-In Period (3 Weeks)

First Treatment Period (3 Weeks)

First Wash Out Period (3 Weeks)

Second Treatment Period (3 Weeks)

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 The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis., measured over 1 yr.

The primary endpoint is mean short-term lower-leg growth velocity, measured in millimeters per week (mm/wk) using knemometry. Knemometry measures changes in lower-leg length over short intervals. The registry describes it as a non-invasive technique and states that it is used in short-duration growth studies. This makes it a way to examine short-term changes rather than a direct measure of longer-term height or overall growth.

The primary comparison concerns the mean growth velocity during the Omnaris-and-Alvesco combination versus the mean during the Beconase-and-QVAR combination. The registry describes the endpoint as a mean and gives a 95% confidence interval for each reported combination. A mean summarizes the observed measurements, while the confidence interval conveys uncertainty around an estimate under the analysis used. It does not describe the range of individual children's measurements.

The outcome description specifies knemometry, but it does not report details such as the exact calculation used to derive velocity from measurements, the number of measurements contributing per participant, or how measurements across visits and treatment periods were combined. Those details are not reported in the registry record. Consequently, the endpoint's general meaning is clear, but the precise analysis behind the posted group estimates cannot be reconstructed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a reported mean represent?

The primary endpoint is continuous: lower-leg growth velocity is measured on a numeric scale, and the registry reports a mean for each combination. In general, a mean is the arithmetic average of the observations included in its calculation. It describes the center of those observations, but by itself does not show their spread or reveal whether measurements were similar across participants. The registry gives no standard deviation or other measure of individual-level variability for these results.

The posted mean for Alvesco and Omnaris is 0.23 mm/wk, with a 95% confidence interval of 0.04 to 0.41. The posted mean for Beconase and QVAR is 0.33 mm/wk, with a 95% confidence interval of 0.14 to 0.51. The endpoint is recorded with a timeframe of 1 yr. The method used to combine or select observations over that timeframe is not reported in the registry record.

What does a confidence interval say?

In general, a confidence interval describes statistical uncertainty about an estimated quantity. A narrower interval indicates greater precision under the chosen analysis and its assumptions; a wider interval indicates less precision. A 95% confidence interval is not an interval containing 95% of participants' measurements. It also does not give the probability that the true value lies within the particular calculated interval. These intervals accompany each posted mean, rather than a direct contrast between the two combinations.

For the comparative question, an estimate of the difference and its confidence interval would be needed to describe both the direction and precision of the contrast. Such a result is not reported in the registry record. In a crossover study, measurements from the same participant under different conditions are related. A suitable comparison generally needs to account for that within-participant relationship. The separate means and confidence intervals do not disclose that relationship, so they cannot reconstruct the uncertainty of the comparison.

Why is the crossover structure relevant?

In general, a crossover design exposes participants to more than one condition in sequence. A comparison can then use within-participant information, which may reduce the influence of stable differences between participants. However, conditions may also differ by period, and an earlier treatment could potentially affect measurements in a later period. Sequence and period effects, carryover, and missing measurements can therefore matter to the analysis. The registry lists six treatment sequences, but does not report the statistical model, handling of period or sequence, assessment of carryover, or any washout procedures.

The record identifies the study as randomized and unmasked. Randomization describes assignment to sequences, while unmasked indicates that masking is listed as none. These design labels do not reveal how randomization was generated or concealed; those details are not reported in the registry record. The record also does not describe whether the analysis followed sequence assignment or used another analysis population.

What can be said about the inferential analysis?

The registry reports no analyses for the outcomes and does not provide a p-value or a direct treatment contrast. The primary outcome is continuous, and the registry note states that values are missing or not estimable for a two-arm comparison. This means the posted arm-level summaries should not be treated as a complete inferential test of the primary question. No recalculated contrast is appropriate when the within-person data structure and analysis details are unavailable.

In general, a p-value evaluates how compatible data are with a specified null model, given the analysis assumptions. It does not measure the size or practical importance of an effect. A confidence interval for the treatment contrast would more directly convey its range of statistical uncertainty. Neither a p-value nor such a contrast interval is reported in the registry record, so the strength and precision of the comparative evidence cannot be characterized using those measures.

What do the planning illustrations mean?

Sample-size planning illustrations are not observed trial results and are not observed power. In general, a planning calculation estimates how many participants per arm might be needed under specified assumptions about the effect to detect, significance level, allocation, and statistical approximation. The stated assumptions for the illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The record does not report the trial's own sample-size justification. Any planning values should be interpreted as hypothetical illustrations under those assumptions, not as a description of the study's actual design rationale or achieved power.

10. Multiplicity, Missing Data and Analysis Populations

The record lists two outcome measures and one secondary outcome. That secondary outcome concerns the effect of Omnaris and Alvesco versus placebo on short-term lower-leg growth velocity measured by knemometry. Numerical results for that secondary comparison are not reported in the registry record. The record lists zero analyses, and the primary two-arm comparison is marked as missing or not estimable.

When a study assesses multiple outcomes or comparisons, multiplicity can arise: the more statistical questions examined, the greater the chance of at least one apparently unusual result under a collection of null hypotheses. In general, study plans may address this by defining a primary outcome, specifying a testing order, or adjusting inference. The registry does not report a multiplicity strategy, a prespecified hierarchy of tests, or how any adjustment was handled. It is therefore not possible to determine whether the primary outcome was treated as the sole confirmatory comparison or how secondary results would have been interpreted.

The crossover sequences include three conditions, while the primary objective compares the two active combinations and the secondary outcome names a placebo comparison. The record does not report the full set of planned contrasts or whether all sequence-based comparisons were analyzed. This limits assessment of the study's complete inferential plan.

Missing data and analysis populations also affect interpretation. The registry lists enrollment of 22, with 21 and 22 participants in the two primary arm summaries. It does not explain the difference between those counts, describe missing visits or measurements, or state how incomplete data were handled. The record does not identify an intention-to-treat, per-protocol, or other analysis population. These aspects are not reported in the registry record, so the impact of missingness and participant inclusion cannot be assessed from the posted summaries.

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 reports serious adverse event figures separately for Alvesco and Omnaris, Qvar and Beconase, and placebo and placebo. The numbers at risk are 21, 22, and 22, respectively. Each group has 0 participants recorded as having a serious adverse event, and deaths are recorded as 0 in each group. These are the serious-event counts in the registry record; they are not a comparison adjusted for the crossover design.

For other adverse events, the record lists 7 affected participants in Alvesco and Omnaris, 7 in Qvar and Beconase, and 6 in placebo and placebo. The registry does not give event terms in these figures or explain how events were attributed when participants experienced more than one treatment condition. The top serious-event terms list is empty.

In general, a count of zero recorded serious events means none were reported in that group in the registry entry; it does not establish that no such events could occur. These counts alone do not describe event severity beyond the serious-event classification, timing, duration, or relationship to treatment. The safety reporting period, definitions, and analysis method are not reported in the registry record. The figures should therefore be read as descriptive counts, not as evidence from a formal comparative safety analysis.

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

The posted results establish that the registry contains arm-level mean estimates for short-term lower-leg growth velocity for two active combinations. The mean is 0.23 mm/wk for Alvesco and Omnaris, with a 95% confidence interval of 0.04 to 0.41. The mean is 0.33 mm/wk for Beconase and QVAR, with a 95% confidence interval of 0.14 to 0.51. The results also establish that a two-arm comparison is not reported as estimable.

Those details do not establish the magnitude or precision of the difference between combinations. Without a direct contrast, its confidence interval, or a p-value, the registry results cannot resolve the primary comparative question. The separate arm means describe estimates on the endpoint scale, but they are not substitutes for a within-person crossover analysis. No claim about a treatment effect should be inferred solely from comparing the means informally.

The outcome is short-term lower-leg growth velocity measured by knemometry. It does not directly provide a measure of longer-term height or overall growth. Although the brief description refers to weekly measurements over 18 weeks, the primary timeframe is listed as 1 yr; the relationship between these descriptions is not reported in the registry record. The endpoint's calculation and the handling of repeated measurements are also not specified.

The study enrolled 22 participants and is marked completed, but the registry does not report participant flow or explain why the primary summaries have different participant counts. It does not report enough information to assess missing data, the analysis population, or the statistical model. These omissions make the findings difficult to evaluate beyond their descriptive content.

In general, statistical uncertainty and clinical relevance are distinct questions. A confidence interval concerns precision under an analysis, whereas judgments about the importance of a change require context that is not established by these summaries alone. The record does not report a threshold for a meaningful difference in lower-leg growth velocity. The posted results should therefore be understood as descriptive estimates with an unreported comparative analysis, rather than as a definitive answer to whether the combinations differ.

13. Why This Trial Matters Statistically

This study is statistically notable because its crossover design raises a comparison question that depends on the relationship between repeated measurements from the same participant. The primary objective is not simply to describe two separate group means: it is to compare lower-leg growth velocity during two combinations. In a crossover study, a direct analysis can use within-participant information, but the methods need to account appropriately for sequence and period structure. Those methods are not reported in the registry record.

The posted estimates are accompanied by 95% confidence intervals, which communicate uncertainty about each mean, but the registry does not post an uncertainty interval for the comparative effect. This distinction illustrates why arm-level summaries alone may not answer a comparative research question, especially when treatment conditions are experienced in sequence. A contrast and its precision are central to interpreting evidence about relative outcomes.

The record also emphasizes the difference between a study being completed and its statistical question being answered in the posted results. The study status is completed, yet the primary two-arm comparison is listed as missing or not estimable. The absence of a reported contrast is a limitation of the available record; it is not evidence that the true difference is zero or that the combinations are equivalent.

Finally, the registry's limited detail on the analysis plan, missing data, outcome timing, and analysis population shows why a statistical result should be read alongside its methods. The study description gives useful context about knemometry and repeated visits, but the inferential approach behind the posted estimates cannot be fully evaluated. This is a reminder that transparent reporting of both estimates and the analysis producing them is essential for interpreting clinical trial results.

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 direct limitation is the lack of an estimable two-arm comparison for the primary endpoint. Although means and confidence intervals are reported for each active combination, the registry does not post a contrast, a confidence interval for the contrast, or a p-value. The primary comparative question is therefore not answered by the posted inferential results.

The record identifies a crossover design with six treatment sequences, but does not state the statistical model or describe how repeated observations, treatment period, sequence, or possible carryover were handled. It also does not report washout procedures. Without these details, the analysis assumptions cannot be assessed. Masking is listed as none; the record does not describe whether outcome measurement or other trial processes were subject to any separate safeguards.

Enrollment is listed as 22, while the primary summaries include 21 and 22 participants. Participant flow and reasons for differing counts are not reported. The registry does not explain missing visits or measurements, define the analysis population, or describe how incomplete observations were treated. The effect of these unknowns on the estimates cannot be determined.

The timing information is also incomplete: the study description says visits were weekly for 18 weeks, whereas the primary endpoint timeframe is recorded as 1 yr. The relationship between these entries is not reported. No details are given about how growth velocity was calculated from knemometry observations or how measurements from treatment periods were aggregated.

Finally, the secondary outcome is named but no numerical secondary result is posted, and the record does not describe a multiplicity plan or the trial's sample-size justification. These gaps limit assessment of the broader analysis and the precision the study was intended to achieve.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis — NCT01550471.
• Registry record last updated 2020-11-04; status last verified 2020-10.
• Results first posted 2020-10-14.
• 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

NCT01550471 is a completed randomized, unmasked, Phase 4 crossover study sponsored by West Penn Allegheny Health System. It enrolled 22 pediatric subjects with mild asthma and allergic rhinitis. The study compared sequences involving Alvesco and Omnaris, QVAR and Beconase, and placebo nasal spray with placebo inhalation aerosol.

The primary endpoint was mean short-term lower-leg growth velocity measured by knemometry in mm/wk. The registry reports means of 0.23 for Alvesco and Omnaris and 0.33 for Beconase and QVAR, with a 95% confidence interval for each mean. It does not report an estimable two-arm comparison. A placebo-related secondary outcome is listed without numerical results. The registry does not report the statistical model, missing-data handling, analysis population, or sample-size justification.