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 AZMATICS: AZithroMycin/Asthma Trial In Community Settings (NCT00266851), a randomized phase 3 study. The primary outcome is Change in Overall Asthma Symptoms From Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00266851 |
| Phase | Phase 3 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 97 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Wisconsin, Madison |
| Results posted | Yes |
2. Clinical Question
Population
Adults with persistent asthma recruited through primary care practice-based research networks. The registry describes a parallel observational cohort for eligible participants who declined randomization. The trial enrolled 97 participants.
Intervention
Azithromycin as adjunctive treatment alongside usual care. The proposed randomized treatment period consisted of 12 weekly doses.
Comparator
Adjunctive placebo alongside usual care in the randomized comparison. The registry also describes an open-label azithromycin observational cohort, which is distinct from the placebo-controlled randomized comparison.
Primary question
Would 12 weeks of azithromycin lead to statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after treatment began? The primary symptom measure was change from baseline in overall asthma symptoms.
The research question combines a statistical question about whether the treatment groups differ with a clinical question about whether any difference is meaningful to patients. Those questions are related but not interchangeable: statistical evidence concerns the compatibility of observed data with a specified comparison, whereas clinical meaning depends on the size and relevance of the change.
The registry lists asthma-specific quality of life, asthma control, and asthma exacerbations among secondary outcomes. It describes the study as a practical clinical trial intended to recruit patients seen in primary care and measure outcomes important to patients. However, the registry record does not report estimates of treatment effects, uncertainty intervals, or statistical tests for the primary question or the secondary outcomes. It therefore does not establish from the posted results whether either part of the research question was answered.
3. Trial Design
AZMATICS was a phase 3, randomized, quadruple-masked, parallel-group study sponsored by the University of Wisconsin, Madison. The registry gives enrollment as 97 and status as completed. The recorded start was 2006-01 and primary completion was 2010-11.
The planned randomized comparison assigned participants to azithromycin or placebo as adjunctive treatment. The registry describes a one-year, blinded trial of 12 weekly doses, with usual care continuing alongside the assigned treatment. Masking was described for investigators, patients, data collectors, and data analysts. Randomization and masking are design features intended to limit bias in group assignment, care, and outcome assessment; the record does not provide further details about how these procedures were implemented.
A parallel observational cohort was also described. Eligible people who declined randomization could enter an open-label azithromycin arm. Because cohort members were not randomized to that treatment, comparisons between the cohort and randomized groups would not have the same protection against confounding as the randomized comparison. The observational cohort should therefore be distinguished from the placebo-controlled trial arms.
The study aimed to recruit adults with asthma through practice-based research networks, with active sites described in Wisconsin and Colorado. The brief summary proposed enrolling 100 adults, while the recorded enrollment is 97. The registry does not explain the difference or report the number assigned to each group as a final enrollment result.
The primary symptom measure was to be collected every 1.5 months for one year. The record also lists secondary outcomes for asthma control, asthma-specific quality of life, and exacerbations. It does not report the statistical analysis plan, allocation ratio actually achieved, or group-specific baseline characteristics. Accordingly, the design can be described from the registry, but details of conduct and analysis cannot be inferred beyond what it states.
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 | Placebo | Azithromycin | Observational Cohort |
|---|---|---|---|
| STARTED | 37 | 38 | 22 |
| Completed 3 Month Follow up | 26 | 22 | 15 |
| Completed 6 Month Follow up | 27 | 22 | 17 |
| Completed 9 Month Follow up | 22 | 23 | 15 |
| Completed 12 Month Follow up | 25 | 19 | 13 |
| COMPLETED | 37 | 38 | 22 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants did not adhere to follow-up schedule
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: all participants who received study intervention or observation
| Characteristic | Unit | Placebo | Azithromycin | Observational Cohort | Total |
|---|---|---|---|---|---|
| Participants analysed | 37 | 38 | 22 | 97 | |
| Age, Continuous | years | 47.4 (SD 14.2) | 45.7 (SD 15.5) | 45.4 (SD 15.2) | 46.3 (SD 14.8) |
| Sex: Female, Male: Female | Participants | 24 | 27 | 10 | 61 |
| Sex: Female, Male: Male | Participants | 13 | 11 | 12 | 36 |
| Race/Ethnicity, Customized: Race – White | Participants | 33 | 36 | 18 | 87 |
| Race/Ethnicity, Customized: Race – Unknown | Participants | 4 | 2 | 4 | 10 |
| Region of Enrollment: United States | participants | 37 | 38 | 22 | 97 |
| Smoking Status: Never | Participants | 13 | 20 | 16 | 49 |
| Smoking Status: Former | Participants | 19 | 12 | 6 | 37 |
| Smoking Status: Current | Participants | 5 | 6 | 0 | 11 |
| Education | years | 15 (10 to 20) | 14 (12 to 22) | 17 (12 to 25) | 15 (10 to 25) |
| Chronic Sinusitis | Participants | 11 | 14 | 19 | 44 |
| Allergy Tested: Negative | Participants | 2 | 1 | 6 | 9 |
| Allergy Tested: Positive for 1-3 positive | Participants | 4 | 3 | 8 | 15 |
| Allergy Tested: Positive for equal to or greater than 4 | Participants | 12 | 14 | 5 | 31 |
| Infectious Asthma | Participants | 6 | 17 | 13 | 36 |
| Exacerbations: Hospitalized | Participants | 0 | 2 | 4 | 6 |
| Exacerbations: Emergency Visit | Participants | 14 | 19 | 9 | 42 |
| Exacerbations: Steroid burst | Participants | 22 | 24 | 13 | 59 |
| Baseline Asthma Severity: Day Symptom Frequency – Mild to Moderate | Participants | 35 | 34 | 15 | 84 |
| Baseline Asthma Severity: Day Symptom Frequency – Severe | Participants | 2 | 4 | 7 | 13 |
| Baseline Asthma Severity: Night Symptom Frequency – Mild to Moderate | Participants | 33 | 33 | 15 | 81 |
| Baseline Asthma Severity: Night Symptom Frequency – Severe | Participants | 4 | 5 | 7 | 16 |
| Coexisting COPD | Participants | 8 | 5 | 2 | 15 |
| Lung Function, FEV | liters in one second | 2.35 (SD 1.31) | 2.33 (SD 1.05) | 2.48 (SD 1.19) | 2.36 (SD 1.16) |
| Lung Function, PEFR | liters per min | 251 (SD 105) | 273 (SD 109) | 300 (SD 105) | 272 (SD 107) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Overall Asthma Symptoms From Baseline, measured over Within the past 24 hours; measured every 1.5 months for one year.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in overall asthma symptoms from baseline, measured in units on a scale. The registry describes a 5-point scale with scores from 0, meaning none, to 4, meaning worst ever; lower scores indicate improvement in asthma symptoms. Symptoms refer to the past 24 hours, and measurements were scheduled every 1.5 months for one year.
Change from baseline is used to express how a participant’s symptom score differs from their own starting measurement. In a randomized comparison, the average change in each arm can be compared to assess whether symptom trajectories differed between treatment assignments. A mean provides a concise summary of a continuous measure, while the standard deviation describes variation among individual measurements around that mean.
These summaries do not, by themselves, convey the full distribution of a bounded symptom scale. The scale has ordered categories, and a mean treats the distances between adjacent scores as comparable. That may be a useful summary, but interpretation also depends on the distribution of scores and on how a change relates to patients’ experiences. The registry does not report a threshold for a clinically meaningful change.
The planned assessment schedule spans one year, while treatment is described as 12 weekly doses. This supports the research question about symptoms after treatment initiation, but does not establish which specific time point or summary across repeated measurements was used for the primary analysis. That analysis detail is not reported in the registry record. Nor are the observed changes, standard deviations, or between-group comparison results reported, so the magnitude and precision of any endpoint difference cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and the trial’s intended comparison, but it does not post an analysis of that outcome. The number of analyses recorded is 0, and the primary-outcome details do not include group means, standard deviations, a treatment-effect estimate, a confidence interval, or a p-value. Consequently, the record does not support a conclusion about the direction, size, or statistical precision of a difference in overall asthma symptoms between randomized groups.
The primary measure is a change in symptom score, for which lower scores indicate improvement. Without the observed group-level changes and the way the comparison was calculated, even the direction of the randomized contrast cannot be established. The registry’s description of a planned question is not evidence that a benefit, no difference, or harm was observed.
The proposed sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations are not observed power and do not substitute for a reported estimate with its uncertainty. The registry record does not provide the underlying observed effect or the numerical planning illustrations needed to evaluate their scale. It also does not report a sample-size justification used in the original trial design.
The listed secondary outcomes are change in asthma control, change in asthma-specific quality of life, and asthma exacerbations. Their outcome labels alone do not show what happened in the groups. No outcome estimates, uncertainty intervals, or analyses for these measures are reported in the registry record. The same limitation applies to any claim about whether findings were statistically significant or clinically meaningful.
The observational cohort adds information about a group offered open-label azithromycin after declining randomization, but it cannot be treated as another randomized arm. Treatment selection was related to declining randomization, and the record does not report an adjusted comparison or other analysis addressing differences between cohort and randomized participants.
Overall, the registry establishes that the study was completed and records its design, enrollment, and intended outcomes. It does not provide the posted efficacy analyses needed to interpret the trial’s primary or secondary findings. This is a limit of what the registry record reports, not evidence that the trial found no difference.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary endpoint is described as a mean of a continuous measure, with standard deviation as its dispersion measure. A mean summarizes the average score or change across participants. The standard deviation describes how spread out individual values are around that average. A mean difference between randomized groups can summarize the contrast in average change, but the registry record does not report the values needed to calculate or interpret such a contrast.
The symptom measure is bounded and has ordered categories. Treating its values as a continuous measure and summarizing them with a mean can be useful, but it may conceal different patterns in the underlying responses. For example, similar means can arise from different distributions of scores. That is a general consideration for scale data, not a claim about the distribution in this trial.
What would a confidence interval add?
In general, a confidence interval describes uncertainty around an estimated effect. It shows a range of values reasonably compatible with the data and the method used to construct it. A narrow interval indicates greater precision than a wide interval, although interpretation also depends on the scale and clinical context. The registry record does not report a confidence interval for the primary outcome, so the precision of any treatment-effect estimate is not available.
A p-value, in general, describes how unusual data at least as extreme as those observed would be under a specified null model and its assumptions. It is not the probability that the null hypothesis is true, nor does it quantify clinical importance. No primary-outcome p-value is reported in the registry record. The sample-size planning assumptions mention a two-sided significance level of 0.05, but that planning value is not an outcome test result.
Why does randomization matter?
Random assignment is intended to make treatment groups comparable in expectation, including on factors that were not measured. That supports causal interpretation of a comparison between the randomized azithromycin and placebo groups, provided the analysis and trial conduct preserve the benefits of randomization. The registry identifies the allocation as randomized but does not report the allocation sequence, concealment procedures, group sizes, or analysis population. Those implementation details cannot be inferred.
Quadruple masking is recorded, and the study summary names investigators, patients, data collectors, and data analysts as blinded. In general, masking can reduce the influence of expectations on care, outcome reporting, data collection, and analysis decisions. The record does not give details about how masking was maintained or assessed.
How should the planning assumptions be read?
The registry describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial was designed with those exact inputs or that any target power was achieved. The actual design justification is not reported in the registry record.
A sample-size illustration indicates the number of participants per arm under stated assumptions. It is not observed power, which is not a useful retrospective measure of whether a completed study produced a reliable answer. In this case, the registry record does not include an observed treatment-effect estimate or the numerical illustrations required to assess what effect sizes those plans correspond to. Therefore, no specific planning target or adequacy judgment can be drawn from the recorded assumptions alone.
What can be inferred from repeated measurements?
The primary symptom measure was scheduled every 1.5 months for one year. Repeated measurements can describe symptom patterns over time, but analyses must account for the fact that measurements from the same participant are related. General approaches may compare a prespecified time point, summarize change across visits, or model trajectories. The registry does not report which approach was used, whether all scheduled measurements were included, or how within-participant correlation was handled.
The record describes the outcome as a mean with standard deviation, but does not state whether the primary comparison used a model, a specific time point, or an adjustment for baseline values. These details are important for interpreting the analysis and its uncertainty. They are not reported in the registry record, so none should be attributed to the trial.
Why distinguish the randomized groups from the cohort?
The observational cohort was open label and included eligible participants who declined randomization. Because cohort membership was not assigned at random, differences between that group and the randomized arms may reflect participant characteristics or preferences as well as treatment. In general, statistical adjustment can address measured differences under assumptions, but it cannot guarantee removal of unmeasured confounding. The registry record does not report a comparative analysis of the cohort or methods for adjustment.
For the randomized question, the relevant comparison is azithromycin versus placebo among participants assigned within the randomized study. The record does not give an analysis population or group-specific results, so it is not possible to determine whether the posted analysis followed an intention-to-treat approach or another approach. The statistical methods actually used are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary symptom outcome and secondary outcomes for asthma control, asthma-specific quality of life, and asthma exacerbations. It does not report how many hypotheses were tested, whether the primary endpoint used a single prespecified contrast, or whether any adjustment was made for multiple outcomes or repeated time points. The reported count of outcome measures is 4, but the analysis count is 0. Those counts do not establish a multiplicity procedure.
Multiplicity matters in general because testing several outcomes or time points can increase the chance of at least one apparently notable result even when no real effect exists. A prespecified hierarchy or adjustment can help control this issue, but no such plan is described in the registry record. It is therefore not possible to judge whether any reported inference accounted for multiple comparisons; no efficacy analyses are reported there in any case.
The primary measure was scheduled repeatedly over one year. The registry does not specify the analysis time point or how the repeated observations were combined, nor does it report whether any visits were missed. The primary-outcome population description states, “All participants did not adhere to follow-up schedule.” This wording signals a follow-up issue but does not quantify missingness, explain its pattern, or identify the analysis population.
Missing data can affect estimates when the likelihood of a missing measurement is related to symptoms, treatment, or other participant characteristics. In general, the consequences depend on why values are missing and on the assumptions and methods used to handle them. The registry record does not report a missing-data strategy, sensitivity analyses, imputation, or the number of participants with observed endpoint data. Thus, the extent to which incomplete follow-up may affect the primary comparison cannot be assessed.
It is also not reported in the registry record whether analyses followed assignment regardless of adherence, excluded participants with incomplete follow-up, or used another population definition. These are important distinctions for interpreting randomized evidence and should not be guessed from the design description.
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 |
|---|---|---|---|
| Placebo | 1 | 37 | 2.7% |
| Azithromycin | 0 | 38 | 0.0% |
| Observational Cohort | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 37 |
| Azithromycin | 0 of 38 |
| Observational Cohort | 0 of 22 |
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 |
|---|---|
| Placebo | 7 of 34 |
| Azithromycin | 16 of 35 |
| Observational Cohort | 14 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Azithromycin | Observational Cohort |
|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 1 of 37 | 0 of 38 | 0 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Azithromycin | Observational Cohort |
|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | 5 of 34 | 12 of 35 | 11 of 20 |
| Stomach Pain | General disorders | 4 of 34 | 11 of 35 | 11 of 20 |
| Nausea | Gastrointestinal disorders | 3 of 34 | 10 of 35 | 8 of 20 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 34 | 3 of 35 | 4 of 20 |
| Vaginal Candidasis | Reproductive system and breast disorders | 3 of 34 | 4 of 35 | 1 of 20 |
| Vomiting | Gastrointestinal disorders | 2 of 34 | 2 of 35 | 2 of 20 |
| Swelling | General disorders | 0 of 34 | 2 of 35 | 2 of 20 |
| Hearing Loss | Ear and labyrinth disorders | 2 of 34 | 1 of 35 | 1 of 20 |
Serious events with the highest arm-level rate: acute myocardial infarction (2.7%).
The registry lists serious adverse events for the placebo, azithromycin, and observational cohort groups. For placebo, 37 participants were at risk for serious events and 1 was affected; for azithromycin, 38 were at risk and 0 were affected; for the observational cohort, 22 were at risk and 0 were affected. Deaths are recorded as 0 in each group. These are the registry’s event counts, not estimates of comparative risk.
The record also lists other adverse events: 7 affected among 34 at risk in the placebo group, 16 among 35 at risk in the azithromycin group, and 14 among 20 at risk in the observational cohort. These figures are separate from the serious-event counts and should not be combined with them. The open-label observational cohort is not a randomized comparator, so its figures do not provide a randomized safety contrast.
Acute myocardial infarction is listed among the top serious adverse event terms with 2.7%. The registry excerpt does not specify the denominator or provide enough detail to interpret that percentage as a group-specific rate. It should therefore be read only as a listed term and percentage, not assigned to a particular treatment group.
Event counts alone do not establish whether groups differ, and differences in the numbers at risk matter when interpreting counts. The registry does not report timing, severity detail beyond the serious-event classification, exposure-adjusted rates, or statistical comparisons. These figures describe what was posted, without establishing causation or a treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record establishes that AZMATICS was a completed randomized, placebo-controlled study of adjunctive azithromycin in adults with persistent asthma, with an observational cohort for people who declined randomization. It also describes a patient-reported symptom scale and planned follow-up over one year. These design details clarify what the trial set out to examine.
They do not establish what the randomized comparison found. The record does not report the primary outcome estimates, their uncertainty, or statistical tests. Without those results, it is not possible to say whether symptom scores changed differently between the randomized groups, how large any difference was, or how precisely it was estimated. The absence of a posted analysis is not evidence that the groups were the same.
The stated research question included both statistical significance and clinical meaningfulness. Statistical significance, in general, concerns evidence against a specified null model. Clinical meaningfulness concerns whether the size and nature of a change matter to patients. A p-value alone would not resolve the latter question, and the registry does not provide a threshold for meaningful change or the effect estimate needed to evaluate it.
The secondary outcome labels and safety counts add context about what was measured, but they do not replace the missing efficacy analysis. Nor can the observational cohort be interpreted as a randomized treatment comparison. Its open-label, nonrandomized structure leaves the possibility that group differences reflect factors other than treatment.
The sound interpretation is therefore limited: the registry records the trial’s design, enrollment, outcome definitions, and some adverse-event counts, but not the analyses needed to answer the research question. No conclusion about benefit, lack of benefit, or harm should be drawn from the design description or from the absence of posted primary results.
13. Why This Trial Matters Statistically
AZMATICS is statistically notable as a practical clinical trial designed around adults with asthma seen in primary care. The stated aim was to combine randomized, blinded comparison methods with outcomes important to patients. That design intention highlights a central challenge in clinical research: maintaining credible comparisons while studying people and outcomes relevant to routine practice.
The trial also separates two kinds of evidence. The randomized azithromycin-versus-placebo comparison is designed to support a causal interpretation, while the open-label observational cohort represents participants who declined randomization. Keeping those groups distinct is essential. A cohort can provide descriptive information, but it does not inherit the balance created by random assignment.
The primary endpoint is a repeated symptom measure on a bounded, ordered scale, summarized as a mean and standard deviation. This raises familiar statistical questions about how a scale is summarized, how repeated measurements are handled, and how change is linked to patient-important meaning. The registry record defines the scale and assessment schedule, but does not report the analysis choices or outcome estimates needed to resolve those questions for this trial.
Finally, the record illustrates why trial registration and posted results serve different purposes. The design and outcome descriptions help readers understand the question, while effect estimates and uncertainty are needed to judge what the study found. In this case, the completed status and recorded enrollment are available, but the primary analysis is not reported in the registry record. Recognizing that distinction prevents a planned research question from being mistaken for an observed finding.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpretation is that the registry record does not report the primary outcome analysis. There are no posted group means, standard deviations, treatment-effect estimates, confidence intervals, or p-values for change in overall asthma symptoms. The record also does not report analyses for the listed secondary outcomes. As a result, efficacy and precision cannot be assessed from the registry information.
The primary-outcome population description says that all participants did not adhere to the follow-up schedule, but gives no count or pattern of missing measurements. The registry does not explain the wording, define the analysis population, or describe methods for handling incomplete follow-up. This prevents assessment of how missingness may have affected the planned repeated symptom measurements.
The registry records enrollment of 97, while the brief summary describes a proposed enrollment of 100. It does not explain the difference or give final group sizes for the randomized arms. Details of allocation implementation, baseline characteristics, treatment adherence, and analysis populations are also not reported in the registry record.
The primary symptom measure is bounded and ordered, but the record describes it using a mean and standard deviation without providing the observed distribution. It does not state how repeated assessments were incorporated into the primary analysis, which time point was primary, or whether baseline adjustment was used. The statistical analysis plan and multiplicity approach are not reported.
Safety interpretation is limited as well. The registry provides counts for serious and other adverse events, but not timing, exposure-adjusted comparisons, or complete context for the listed acute myocardial infarction percentage. The observational cohort was open label and nonrandomized, so it should not be treated as an equivalent randomized arm. These limits apply to interpretation of the registry record and do not establish what may have been reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: AZMATICS: AZithroMycin/Asthma Trial In Community Settings — NCT00266851.
- Registry record last updated 2019-09-06; status last verified 2019-07.
- Results first posted 2019-09-06.
- 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
AZMATICS was a completed phase 3, randomized, quadruple-masked, parallel-group study sponsored by the University of Wisconsin, Madison. Recorded enrollment was 97. The registry describes a planned comparison of adjunctive azithromycin with placebo in adults with persistent asthma, alongside an open-label observational cohort for eligible participants who declined randomization.
The primary outcome was change from baseline in overall asthma symptoms, measured on a 5-point scale from 0, none, to 4, worst ever; lower scores indicate improvement. Measurements were scheduled every 1.5 months for one year. Secondary outcomes included asthma control, asthma-specific quality of life, and exacerbations.
The registry records serious and other adverse-event counts and 0 deaths in each listed group. It does not report the primary outcome analysis, statistical methods, missing-data approach, or comparative efficacy estimates. The posted record therefore describes the study and its measures but does not establish the trial’s primary result.