Effectiveness of the Aeroneb in Acute Severe Asthma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effectiveness of the Aeroneb in Acute Severe Asthma (NCT03029156), a randomized na study. The primary outcome is Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial with single masking, listed as completed. The enrollment was 31: 15 participants in the small volume jet nebulizer group and 16 in the Aeroneb group. The registry lists the phase as NA. The sponsor was Tufts Medical Center. The recorded start was 2015-08 and primary completion was 2018-12.

Random allocation is intended to create groups that are comparable on average, including for factors that were not measured. In a small trial, chance differences in participant characteristics can remain, so the group summaries should not be taken as proof that every relevant characteristic was balanced. The registry record does not report the randomization sequence method, allocation concealment, or which people were masked.

The two arms received the same named bronchodilator components through different delivery devices: ipratropium / albuterol through Aeroneb or through a small volume jet nebulizer. The brief description says treatment followed the emergency room protocol. Details of that protocol and of any other care are not reported in the registry record.

The primary endpoint was measured 30 minutes after initial treatment. Secondary outcomes include PEFR and FEV1 change to disposition, change in Borg-Dyspnea score, heart-rate change, emergency-room length of stay, hospitalization, and total albuterol dose. The registry record does not report a full protocol, the trial’s original sample-size justification, or the statistical analysis plan. It also does not report an interim-analysis plan or details of the analysis populations.

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

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 Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment, measured over 30 minutes.

The primary endpoint is the percentage change in mean peak expiratory flow rate (PEFR) percentage of predicted baseline, measured 30 minutes after the initial bronchodilator treatment. PEFR is the maximum flow rate generated during a forceful exhalation starting from full inspiration. Expressing PEFR as a percentage of predicted baseline relates the measurement to a predicted reference value; the endpoint then describes its percentage change at the stated follow-up.

PEFR is used as a measure of airflow during an asthma exacerbation. A change after treatment can describe how that measurement varies over the specified interval. The endpoint focuses on a relatively early measurement, rather than the broader set of outcomes recorded through disposition. It is distinct from FEV1, dyspnea scores, heart rate, length of stay, hospitalization, and medication dose.

The registry reports the group means and standard deviations for this primary measure. The small volume jet nebulizer group had a mean of 18.1 and standard deviation of 18.01 among 15 participants; the Aeroneb group had a mean of 12.9 and standard deviation of 13.36 among 16 participants. The estimated mean difference, expressed as Aeroneb minus small volume jet nebulizer, was -5.2. The confidence interval and its interpretation are important because the point estimate alone does not convey the uncertainty around the estimated difference.

7. Results Posted in the Registry

• Aeroneb Nebulizer: mean 12.90 versus 18.10 on control; difference -5.20 (95% CI -16.42 to 6.02), standardized effect d = -0.33; z-test p = 0.364.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Aeroneb Nebulizer: mean 14.40 versus 23.30 on control; difference -8.90 (95% CI -19.20 to 1.40), standardized effect d = -0.61; z-test p = 0.090.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Aeroneb Nebulizer and the control. The interval gives the range of effects that remain compatible with the data.

Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Aeroneb Nebulizer: mean 8.00 versus 17.10 on control; difference -9.10 (95% CI -16.80 to -1.40), standardized effect d = -0.84; z-test p = 0.021.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Aeroneb Nebulizer than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in the Borg-Dyspnea Score From Baseline to Disposition

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Aeroneb Nebulizer: mean 3.15 versus 2.44 on control; difference 0.71 (95% CI 0.21 to 1.21), standardized effect d = 0.97; z-test p = 0.005.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Aeroneb Nebulizer than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes broaden the assessment beyond the early primary PEFR measurement. They include PEFR and FEV1 through disposition, Borg-Dyspnea score, heart rate, emergency-room length of stay, hospitalization, and total albuterol dose. The detailed posted numerical comparisons cover PEFR through disposition, FEV1, and Borg-Dyspnea score. Numerical results for the other listed outcomes are not reported in the registry record.

Across the detailed secondary comparisons, the pattern is not uniform. The PEFR comparison through disposition is directionally consistent with the primary PEFR point estimate, while the posted FEV1 and Borg-Dyspnea comparisons point in the opposite direction. These are different measures, and their observation periods and scales differ. They should not be treated as interchangeable measurements of a single outcome or as a vote in which one direction wins.

The secondary findings also do not replace the primary comparison. The primary question concerns PEFR at 30 minutes; the secondary measures address later PEFR, a distinct lung-function measure, a symptom score, and other aspects of emergency-room care. A difference in one secondary measure does not resolve uncertainty in the primary measure.

General: when many outcomes are tested, the chance of at least one apparently notable result can increase. An unadjusted p-value for one secondary outcome does not account for the fact that other outcomes were also examined. Prespecified outcome hierarchy, multiplicity adjustment, and interpretation in light of all outcomes can help prevent overemphasis on a single result. Such a plan is not reported in the registry record. The secondary results are consequently best treated as exploratory and interpreted in the context of their uncertainty, the trial’s small enrollment, and the mixed direction of the comparisons.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
• Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
• Change in the Borg-Dyspnea Score From Baseline to Disposition
• Change in Heart Rate Baseline to Disposition
• Length of Stay in the ER
• Percentage of Patients Requiring Hospitalization
• The Total Dose of Albuterol Used in Each Group During ED Stay

9. Statistical Interpretation

10. Statistical Methods Explained

The registry identifies a continuous primary outcome summarized by group means and standard deviations. It also posts a mean difference, confidence interval, and unadjusted p-value. The exact statistical test or model used for the sponsor’s analysis is not reported in the registry record. The explanation below distinguishes general statistical principles from details of this particular trial.

What does a mean difference represent?

For a continuous outcome, a group mean is the average of participant measurements in that group. The posted primary means are 18.1 for the small volume jet nebulizer and 12.9 for Aeroneb. The reported contrast is Aeroneb minus small volume jet nebulizer, giving -5.2. A negative value means the observed Aeroneb group mean was lower for this endpoint. The contrast is expressed in the endpoint’s units, here percentage change.

General: a mean difference preserves the original measurement scale and describes the difference between group averages. It does not state that every participant experienced a change of that size, and it does not by itself establish why the groups differed. Randomization supports a causal comparison in principle, but small enrollment and uncertainty remain important when interpreting the estimate.

What do standard deviations describe?

The registry reports standard deviations of 18.01 for the small volume jet nebulizer group and 13.36 for Aeroneb for the primary endpoint. A standard deviation describes how dispersed individual observations are around their group mean. It is not a confidence interval for the mean and is not the same quantity as the standard error. The registry does not report individual participant values, so the distribution and any outliers cannot be assessed from these summaries alone.

General: variability among participants affects the precision of a comparison. Greater variability can make a group difference harder to estimate precisely for a given sample size. It is possible for groups to have different means while individual measurements overlap substantially; the group means and standard deviations do not reveal each participant’s response.

How should the p-value be read?

The primary unadjusted p-value is 0.364. General: a p-value measures how unusual the observed data, or more extreme data, would be under a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, nor the probability that a result arose “by chance.” Its interpretation depends on the analysis assumptions, which are not reported in the registry record.

The registry lists unadjusted p-values for secondary comparisons as well. Unadjusted means that the displayed p-value is not presented as corrected for the collection of outcomes or comparisons. When multiple outcomes are examined, some small p-values can occur even if no underlying effects exist. A planned hierarchy or multiplicity procedure can address this issue, but such procedures are not reported in the registry record.

What does the confidence interval add?

The primary 95% confidence interval runs from -16.42 to 6.021. General: a confidence interval gives a range of values compatible with the data under the assumptions of the analysis, while also conveying sampling uncertainty. In repeated use of the same valid procedure, intervals constructed in this way would cover the true parameter at the stated rate. The interval is not a guarantee that the true difference lies within its endpoints, and it is not a range containing a stated proportion of individual responses.

Because the primary interval includes zero, it does not distinguish a zero mean difference from values on either side at the confidence level used. Its width also matters: the endpoint estimates are not very precise. The p-value and interval are related aspects of the same comparison, although the exact test and interval construction are not reported in the registry record.

What can be inferred about the analysis?

The comparison statistics are posted, but the analysis plan, adjustment variables, handling of missing observations, and analysis population are not reported in the registry record. It is therefore not possible to determine whether the displayed summaries represent all randomized participants, participants with an observed measurement, or another analysis set. The registry record also does not specify how repeated measurements or departures from a planned measurement time were handled.

General: an analysis plan helps distinguish prespecified tests from analyses chosen after looking at results. Prespecification limits selective emphasis and clarifies which population, outcome, and time point answer the main question. Without the plan, the numerical comparisons can still be described, but their status within the sponsor’s full analysis strategy is unclear.

What do the planning calculations mean?

The registry includes sample-size planning illustrations based on observed effect estimates. These use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the target effect is a stated fraction of the observed effect. General: such calculations estimate the sample size that would be needed under chosen assumptions to detect a target difference at a specified power. They are not a record of the trial’s original design assumptions. Those original assumptions are not reported in the registry record.

The planning values should not be confused with observed power. General: observed power calculated from the final estimate largely restates the result and does not resolve uncertainty; the confidence interval is more informative for judging precision. Planning calculations are sensitive to the assumed effect and variability, and assumptions based on a small study can be uncertain. The registry describes these calculations as planning illustrations, not as the trial’s own design justification.

11. Confidence Intervals and Precision

The primary estimated mean difference is -5.2, with a 95% confidence interval from -16.42 to 6.021. This interval is central to interpretation because it shows the range of values compatible with the comparison under the analysis assumptions. It includes zero, so the posted result does not sharply distinguish a negative difference from no difference or a positive difference. The point estimate alone would give an incomplete picture.

The interval also indicates limited precision. Its endpoints span a considerable range of possible mean differences, relative to the estimate. The trial enrolled 31 participants, with 15 in the small volume jet nebulizer arm and 16 in the Aeroneb arm. With group sizes of this scale, estimates can be sensitive to participant-to-participant variation. The posted standard deviations, 18.01 and 13.36 respectively, describe notable dispersion in the observed primary measurements, though no individual observations are reported.

General: a confidence interval is not a range for individual participants and does not assign probabilities to each possible true effect. It expresses uncertainty about the population contrast under a statistical procedure and its assumptions. The registry record does not report the exact method used to construct the interval, which limits assessment of those assumptions.

The unadjusted p-value of 0.364 is consistent with the interval including zero, but it should not replace examination of the effect estimate and interval. Neither a non-significant p-value nor an interval that includes zero establishes equivalence. The registry record does not report an equivalence margin, a noninferiority margin, or a design intended to establish either conclusion.

Precision is also distinct from clinical importance. The registry does not report a threshold for a clinically meaningful PEFR difference. Therefore the interval can be discussed statistically, but the posted information does not establish which values within it would matter clinically.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning illustrations give participants per arm, not total events. They are based on the observed effect, with rows for planning for 100%, 75%, or 50% of that observed effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each power column describes a different target probability of detecting the chosen effect under those planning assumptions: 80% power or 90% power.

In plain terms, planning for 80% power means choosing a sample size that would give an 80% chance of a statistically significant result if the assumed effect and other planning assumptions were true. Planning for 90% power uses a higher target chance and therefore generally requires more participants under the same assumptions. These are design calculations, not descriptions of what happened in the completed trial. They are not observed power.

The effect size used in the illustration matters. A smaller target difference is harder to distinguish from random variation, so smaller effects need more participants. The rows for a fraction of the observed effect illustrate how sample-size needs change when planning for less than the full observed estimate. Because the observed effect in a small trial can itself be uncertain, these values should be read as assumption-dependent illustrations rather than definitive requirements.

The original trial’s sample-size assumptions and justification are not reported in the registry record. The planning illustrations are explicitly based on observed effects and should not be interpreted as evidence that the trial was designed with those targets or achieved the listed power.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -5.200; pooled standard deviation σ = 15.777.
2. n = 2 × (1.96 + 0.842)² × 15.777² / -5.200² = 144.5, rounded up to 145 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -5.2                      # observed difference in means
sigma <- 15.7768767941982                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3029156)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 145 (80% power), 194 (90% power)
 75% of observed effect: n per arm = 257 (80% power), 344 (90% power)
 50% of observed effect: n per arm = 579 (80% power), 774 (90% power)
power.t.test: 145.5 
Simulated power at n = 145 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and multiple secondary outcomes. The primary endpoint is PEFR percentage change at 30 minutes. The secondary outcomes cover PEFR and FEV1 through disposition, dyspnea score, heart rate, emergency-room length of stay, hospitalization, and albuterol dose. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a plan specifying how secondary outcomes would be interpreted alongside the primary result.

General: testing several outcomes creates more opportunities for an apparently unusual result. A multiplicity strategy may control the overall chance of false-positive findings or specify that secondary tests are descriptive. Without a reported strategy, unadjusted secondary p-values should not be read as if each were the only hypothesis tested. This matters especially when secondary findings do not all point in the same direction.

Missing-data methods are not reported in the registry record. The posted outcome summaries include group sizes, but the record does not explain whether all randomized participants contributed to every endpoint, whether measurements were missing, or how any missing measurements were handled. It also does not report whether participants were analyzed according to randomized assignment or whether another analysis population was used.

These omissions affect interpretation rather than changing the arithmetic of the posted summaries. If outcome availability differed between arms, or if the analysis population differed from all randomized participants, the reported group comparisons might not represent the full randomized groups in the same way. The registry record does not provide enough information to evaluate those possibilities.

The record also does not report the sponsor’s detailed statistical analysis plan, including covariate adjustment, assumptions for the comparison, or how protocol deviations were handled. The posted unadjusted comparisons can be described as reported, but the absence of these details limits independent assessment of whether the analysis followed a prespecified plan.

15. 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.

The registry reports 0 serious adverse events among 15 participants at risk in the small volume jet nebulizer group and among 16 participants at risk in the Aeroneb group. It also reports 0 other adverse events in each group and 0 deaths in each group. No serious adverse-event terms are listed.

These figures describe the events recorded in this trial; they do not establish that no events could occur. The groups were small, and the record does not provide further details about event definitions, collection procedures, observation duration, or whether particular events were actively sought. The adverse-event summaries should therefore be read as a record of what was reported during this study, not as a comprehensive estimate of event risk.

General: zero recorded events in a limited sample can coexist with uncertainty about uncommon events. The absence of reported serious events does not, by itself, demonstrate that the devices have identical safety profiles. The registry record does not provide enough information to make broader comparative safety conclusions.

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

The posted primary result describes mean PEFR percentage change at 30 minutes after initial bronchodilator treatment. The mean was 18.1 in the small volume jet nebulizer group and 12.9 in the Aeroneb group. The estimated Aeroneb-minus-jet mean difference was -5.2, and its 95% confidence interval ranged from -16.42 to 6.021. The estimate is uncertain and compatible with a range of differences that includes zero.

This result does not establish equivalence between the devices. A study designed to show equivalence or noninferiority would require a prespecified margin and an analysis framed around that question; neither is reported in the registry record. Likewise, the primary unadjusted p-value of 0.364 should not be translated into proof that there is no difference.

The result also does not establish a general effect across all asthma exacerbations, all clinical settings, or all patient groups. The registry describes an emergency-room population of adults aged 18 to 55 years with severe exacerbation and PEFR below 50% of predicted. The trial enrolled 31 participants. Information about other populations and settings is not reported in the registry record.

Secondary outcomes add context but are not a uniform confirmation of the primary result. Some point in a different direction, and the detailed comparisons are unadjusted. Numerical results for several listed secondary outcomes are not reported in the registry record. These limitations make it inappropriate to compress the results into a single broad statement about all measured outcomes.

The serious adverse-event summaries report no events in either group, but the small number of participants and absence of additional event-collection details limit what can be concluded from those counts. Taken together, the record supports a precise description of the reported group outcomes and their uncertainty, not medical advice or a recommendation about which device to use.

17. Why This Trial Matters Statistically

This trial illustrates why the estimated effect and its precision should be considered together. The primary point estimate is a single value, but the confidence interval extends across zero and spans a broad set of possible differences. Looking only at the sign of the point estimate would give more certainty than the data warrant; looking only at the p-value would also omit the range of effects compatible with the estimate.

The study also shows the interpretive limits of a small randomized comparison. Randomization is valuable because it aims to balance groups, but it does not guarantee balance in every small sample. With 31 participants overall, estimates can remain uncertain even when allocation is randomized. The reported standard deviations also indicate variation in the observed measurements, making precision a central part of the result.

The outcome structure matters. The primary endpoint is a specific early PEFR measure, while secondary endpoints address other lung-function measures, symptoms, and care outcomes. Differences across measures and timeframes need not agree, and a list of unadjusted secondary tests increases the importance of a prespecified interpretation plan. That plan is not reported in the registry record.

Finally, planning calculations based on observed effects should not be confused with the trial’s original design assumptions or with evidence that a result is adequately powered. The posted planning figures illustrate how assumptions about target effect and power affect participant requirements, but the original sample-size justification is not reported. The trial is therefore a useful example of separating observed results, uncertainty, exploratory findings, and future-study planning.

18. 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 trial enrolled 31 participants, so the primary and secondary group estimates have limited precision. The primary confidence interval includes zero and extends across a broad range of possible mean differences. The registry record does not report a threshold for a clinically meaningful difference, which prevents judging the interval against a stated clinical criterion.

The registry provides limited detail about conduct and analysis. Although allocation is listed as randomized, the randomization method and allocation concealment are not reported in the registry record. Masking is listed as single, but the identity of the masked parties is not reported. Details of the emergency-room treatment protocol, including treatment schedule and dose, are also not reported.

The statistical analysis plan, the original sample-size justification, the analysis populations, and the handling of missing data are not reported in the registry record. The record does not describe whether covariates were used, how protocol deviations were handled, or how the reported confidence intervals were constructed. These omissions make it difficult to assess the analysis beyond the posted group summaries and comparisons.

Several secondary outcomes are listed, but the posted detailed numerical comparisons cover only some of them. The registry record does not report numerical results for heart rate, emergency-room length of stay, hospitalization, or total albuterol dose. The record also does not describe a multiplicity procedure. Consequently, the secondary findings should be interpreted cautiously and not treated as definitive confirmation.

Safety summaries show no reported adverse events in the small groups, but further details about event definitions and collection are not reported in the registry record. These limitations are specific to the information available for this trial and constrain the breadth of conclusions that can be drawn.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effectiveness of the Aeroneb in Acute Severe Asthma — NCT03029156.
• Registry record last updated 2023-05-19; status last verified 2023-05.
• Results first posted 2023-05-19.
• 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.

22. Record Summary

NCT03029156 is a completed, randomized, parallel-group, single-masked trial comparing Aeroneb with a small volume jet nebulizer for delivery of ipratropium / albuterol during severe asthma exacerbation. Enrollment was 31. The primary outcome was mean percentage change in PEFR percentage of predicted baseline 30 minutes after initial treatment.

The posted primary mean difference for Aeroneb minus small volume jet nebulizer was -5.2, with a 95% confidence interval from -16.42 to 6.021 and an unadjusted p-value of 0.364. The interval includes zero and indicates uncertainty in the size and direction of the difference. Secondary outcomes show a mixed pattern, and the registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths in each group.

The registry record does not report the original sample-size justification, detailed analysis plan, missing-data methods, or multiplicity strategy. Those omissions limit interpretation of the posted comparisons and planning illustrations.