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 Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528 (NCT00483041), a randomized phase 2 study. The primary outcome is Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00483041 |
| Phase | Phase 2 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | MedImmune LLC |
| Results posted | Yes |
2. Clinical Question
Population
Adults with atopic asthma were eligible for the study. The registry record says 11 subjects were randomized, 10 received at least one dose of study product, and 2 completed the baseline and follow-up bronchoalveolar lavage and segmental allergen challenge procedures. The record does not give further participant characteristics.
Intervention
The active intervention was MEDI-528 at 9 mg/kg, given as a single intravenous infusion. MEDI-528 is described in the official title as a humanized anti-interleukin-9 monoclonal antibody. The study was intended to assess its effect on IL-9 levels following allergen challenge.
Comparator
The comparison group received placebo as a single intravenous infusion. The study used randomized allocation, double masking, and a parallel-group model. The registry record does not report details about how the random sequence was generated or how masking was maintained.
Primary question
The primary endpoint listed was total IL-9 counts in bronchoalveolar lavage fluid, measured by enzyme-linked immunosorbent assay and reported in picograms per milliliter. The question was whether the IL-9 response to segmental allergen challenge differed after MEDI-528 compared with placebo. Numerical endpoint results and a reported between-group analysis are not reported in the registry record.
3. Trial Design
The registry identifies NCT00483041 as a randomized, double-blind, parallel-group Phase 2 study. Its official title describes it as Phase2A and specifies a placebo-controlled evaluation of a single intravenous dose of MEDI-528. The listed interventions were MEDI-528 at 9 mg/kg and placebo, each administered as a single intravenous infusion.
Enrollment was 11. The record lists the study start as 2007-07 and primary completion as 2008-10, with status recorded as terminated. It does not report why the study was terminated, whether termination followed a planned review, or whether the termination was related to safety, recruitment, or another issue. Those explanations should not be inferred from status alone.
The primary outcome concerned IL-9 in bronchoalveolar lavage fluid after a segmental allergen challenge. The stated measurement timeframe was baseline, 2 to 4 weeks prior to Day 0, and Day 15. The outcome description also refers to procedures at baseline and on Days 14 and 15. It states that the intended response was biologically active IL-9 after allergen application, before and 2 weeks after investigational product administration.
The endpoint population description reports that 11 subjects were randomized, 10 received at least one dose, and 2 completed the required baseline and follow-up procedures, with 1 subject in each treatment group. The registry record lists secondary outcomes covering adverse events, anti-drug antibodies, and pharmacokinetic measures, but numerical results for those outcomes are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Treatment assignments were determined using a block randomization procedure with a 1:1 ratio through an interactive voice response system. Only participants who had detectable levels of interleukin-9 in the Baseline Visit 2' bronchioalveolar lavage sample will be randomized.
Overall Study
| Stage | PLACEBO | MEDI528 9 mg |
|---|---|---|
| STARTED | 5 | 6 |
| COMPLETED | 5 | 5 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | PLACEBO | MEDI528 9 mg |
|---|---|---|
| ABNORMAL LAB DATA AT SCREENING | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | PLACEBO | MEDI528 9 mg | Total |
|---|---|---|---|---|
| Participants analysed | 5 | 6 | 11 | |
| Age, Continuous | Years | 29.2 (SD 7.8) | 22.3 (SD 2.7) | 25.5 (SD 6.4) |
| Sex: Female, Male: Female | Participants | 3 | 1 | 4 |
| Sex: Female, Male: Male | Participants | 2 | 5 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL), measured over Baseline (2 to 4 weeks prior to Day 0) and Day 15.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Picograms per milliliter |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was a listing of total interleukin-9 (IL-9) counts in bronchoalveolar lavage (BAL) fluid, measured by enzyme-linked immunosorbent assay and expressed in picograms per milliliter. BAL fluid is collected from the airways, and the endpoint was intended to characterize the IL-9 response to a segmental allergen challenge. The record describes measurement at baseline and Day 15, with the challenge procedures conducted at baseline and on Days 14 and 15.
As general statistical context, a biological measurement can help describe whether a study intervention is associated with a change in a targeted process. A concentration measurement also retains more information than a simple yes-or-no outcome, but its interpretation depends on the observed values, their variability, and the analysis used. The endpoint title calls for a listing of counts; it does not itself establish that a particular statistical comparison was performed.
The record says that only 2 subjects completed the specified BAL and allergen challenge procedures at baseline and follow-up, with 1 subject in each treatment group. Numerical IL-9 values, a measure of variability, and a reported primary comparison are not reported in the registry record. Consequently, the listed endpoint describes what investigators intended to measure, but the available record does not establish the size or precision of any treatment-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a biological endpoint but does not report numerical IL-9 measurements or a primary statistical analysis. It lists total IL-9 counts in BAL fluid, measured by enzyme-linked immunosorbent assay, and specifies baseline and follow-up timing around segmental allergen challenge. The outcome listing is not a numerical estimate of the treatment effect. Without endpoint values and a stated comparison, the direction, magnitude, and precision of a difference between MEDI-528 and placebo cannot be assessed from the record.
The endpoint population description is especially important for interpretation. Although 11 subjects were randomized and 10 received at least one dose, only 2 completed the BAL and allergen challenge procedures at both baseline and follow-up. The record identifies 1 subject in each treatment group among those completing the procedures. This leaves very little completed endpoint information in the registry record. It does not report the reasons that other randomized or dosed subjects did not contribute the specified endpoint measurements, so those reasons should not be assumed.
The posted safety figures list 5 subjects at risk in each group for serious adverse events and 0 affected in each group. For other adverse events, 5 subjects were at risk and 5 were affected in each group. These are descriptive counts. The record does not provide event terms, severity, timing, attribution, or a detailed definition of the non-serious category, and it does not report deaths. The small group counts and limited event detail do not support broad conclusions about comparative safety.
The record lists 13 outcome measures and no analysis records. It also does not report a statistical analysis plan, a method for handling missing endpoint data, or a reason for termination. The absence of a reported result is not evidence that the treatment groups had the same IL-9 response, nor does it show that one group had a larger response. It means the registry record does not provide enough outcome information to make that comparison.
In general, statistical precision depends on the amount and variability of the observed data. When only a small number of subjects complete an endpoint, estimates can be highly uncertain, and a single observation can have substantial influence. Here, because numerical endpoint measurements and an analysis are not reported, even a quantitative description of uncertainty cannot be made from the registry record. Any planning illustration based on an observed effect should not be mistaken for an observed-power result or for evidence of a treatment effect.
9. Statistical Methods Explained
The registry describes a randomized, double-blind, parallel-group study, but it does not report the statistical methods used to analyze the primary endpoint. The outcome is described as a listing of total IL-9 counts by enzyme-linked immunosorbent assay. No numerical results, comparison estimate, confidence interval, or p-value for that endpoint are reported in the registry record. Accordingly, the methods that follow explain general statistical concepts relevant to interpreting such an outcome; they do not describe an analysis known to have been used in this study.
What does randomization contribute?
General: Randomization assigns participants to study groups using a chance-based process. Its purpose is to reduce systematic differences between groups at the start of a study, so that a subsequent comparison can be interpreted more plausibly as an effect of assignment rather than a consequence of how participants were selected. Randomization does not guarantee that groups will be similar in every characteristic, especially in a small study. The registry records randomized allocation but does not report the sequence-generation method, allocation concealment, or further implementation details.
What does double masking mean for interpretation?
General: Masking is intended to limit the influence of treatment knowledge on participant experience, clinical care, and outcome assessment. The registry records double masking, but it does not specify which people were masked or how masking was maintained. The label alone does not establish whether masking was successful throughout the study.
How should an IL-9 concentration endpoint be analyzed?
General: A measured concentration can be summarized by its observed values and an appropriate description of their location and spread. A comparison might focus on follow-up values, change from baseline, or a model that accounts for repeated measurements, but the choice depends on the protocol, data structure, and assumptions. The registry record does not report which approach was specified or used. It also does not provide the individual values or a measure of variability, so no such analysis can be reconstructed from the record.
General: Concentration data may be skewed, and measurements can vary substantially across participants. A suitable method depends on the observed distribution and scientific question. Over-dispersion, in general, means that count data vary more than a chosen statistical model expects; ignoring it can make uncertainty estimates too small. The endpoint is described as total IL-9 counts, but the registry does not report a dispersion measure, a distributional assessment, or a count-data model. It would therefore be inappropriate to claim that a particular distribution or model fits these data.
What do confidence intervals and p-values ordinarily convey?
General: A confidence interval gives a range of values compatible with the data under a specified statistical procedure and its assumptions. It conveys uncertainty around an estimate, rather than giving the probability that a particular treatment effect is true. A p-value assesses how unusual data at least as incompatible with a specified null model would be if that model held. Neither measure replaces the estimated effect or its clinical interpretation. No primary confidence interval or p-value is reported in the registry record.
What can the planning assumptions tell readers?
The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are assumptions for an illustration, not the trial’s own reported sample-size justification. The record does not report that justification. Because the primary outcome has several categories or time points and is not reduced to one comparison, no single primary comparison is specified for this purpose in the record.
General: Sample-size planning estimates how many observations might be required under stated assumptions to attain a target probability of detecting a defined effect. Such calculations depend on assumptions about the effect, variability, significance threshold, and design. An illustration that takes an observed effect as its starting point is not an estimate of observed power and does not establish that the original study was adequately planned. The sample-size assumption description also distinguishes time-to-event illustrations, which give total events using a Schoenfeld approach, from other illustrations, which give participants per arm. The record does not report a protocol-based sample-size calculation.
Why does the number completing the endpoint matter?
General: Randomized enrollment and endpoint completion are different quantities. The registry reports 11 randomized subjects, 10 who received at least one dose, and 2 who completed the stated endpoint procedures. When few participants contribute endpoint data, estimates may be unstable and may not represent all randomized participants. The record does not explain the missing endpoint observations or report an analysis that addresses them. No particular imputation, exclusion, or sensitivity method can be attributed to the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures, including the primary IL-9 endpoint and secondary outcomes covering adverse events, anti-drug antibodies, and pharmacokinetic measures. It does not report a multiplicity strategy, such as a prespecified order of testing or an adjustment for multiple comparisons. General: When many outcomes or time points are examined, the chance of obtaining at least one apparently notable result can increase. A prespecified approach helps readers understand which comparisons were confirmatory and how the overall interpretation accounts for multiple testing. No such approach is reported in the registry record.
The primary outcome description includes more than one time point and describes a listing of total counts rather than a single reported comparison. The record explicitly does not reduce the primary outcome to one comparison. It also lists no analysis records. As a result, there is no reported primary contrast, testing hierarchy, or multiplicity-adjusted result to interpret.
The endpoint population description reports 11 randomized subjects, 10 who received at least one dose, and 2 who completed the required baseline and follow-up BAL and allergen challenge procedures. The reasons that the other participants did not complete those procedures are not reported in the registry record. The record also does not state how missing endpoint values were handled, whether the analysis followed an intention-to-treat population, or whether a per-protocol or other analysis population was defined. These details should not be inferred from the enrollment counts.
General: Missing-data methods rely on assumptions about why measurements are absent and how missingness relates to observed or unobserved outcomes. Different assumptions can lead to different estimates. Without a reported missing-data method and information about reasons for non-completion, the potential impact of missing endpoint measurements cannot be quantified from this record.
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 | 0 | 5 | 0.0% |
| MEDI528 9 mg | 0 | 5 | 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 |
|---|---|
| PLACEBO | 5 of 5 |
| MEDI528 9 mg | 5 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PLACEBO | MEDI528 9 mg |
|---|---|---|---|
| Post procedural complication | Injury, poisoning and procedural complications | 4 of 5 | 5 of 5 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 2 of 5 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 2 of 5 |
| Fatigue | General disorders | 0 of 5 | 2 of 5 |
| Sinusitis | Infections and infestations | 0 of 5 | 2 of 5 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 1 of 5 | 1 of 5 |
| Procedural headache | Injury, poisoning and procedural complications | 0 of 5 | 2 of 5 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 1 of 5 |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 1 of 5 |
| Pruritus | Skin and subcutaneous tissue disorders | 2 of 5 | 0 of 5 |
The serious adverse event figures list 5 subjects at risk in the placebo group and 5 in the MEDI528 9 mg group. The number affected by serious adverse events is 0 in each group. These counts describe what the registry reports; they do not establish that serious adverse events were impossible or that the treatments have equivalent safety.
For other adverse events, the record lists 5 subjects at risk and 5 affected in each group. It does not provide the event terms, severity, onset, duration, or relationship to study treatment. The figures therefore cannot show which events occurred or whether their clinical character differed between groups. The registry lists adverse events and serious adverse events as secondary outcomes, but it does not report numerical detail beyond these summary counts.
Deaths are not reported in the registry record. General: Safety counts are most informative when read alongside the number of participants observed, the event definitions, event details, and follow-up duration. With these details absent and few subjects at risk, the counts offer only a limited description of reported events; they should not be interpreted as a precise estimate of comparative risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-blind, placebo-controlled Phase 2 study was conducted to evaluate a single intravenous infusion of MEDI-528 at 9 mg/kg in adults with atopic asthma. Its primary outcome was total IL-9 counts in BAL fluid after segmental allergen challenge, measured by enzyme-linked immunosorbent assay. It also records the number randomized, the number dosed, and the number completing the specified endpoint procedures.
The record does not report numerical IL-9 results or a primary treatment comparison. It therefore cannot establish whether IL-9 measurements differed between MEDI-528 and placebo, how large any difference might have been, or how precisely it was estimated. The absence of a reported comparison should not be read as evidence of no difference, just as the planned biological question should not be treated as evidence of a difference.
Only 2 subjects completed the primary endpoint procedures at both baseline and follow-up, with 1 subject in each treatment group. This sharply limits the endpoint information available in the registry. The record does not explain why the remaining participants did not contribute the specified measurements, and it does not describe a missing-data analysis. These gaps prevent a fuller assessment of selection, uncertainty, and possible bias.
The safety counts show 0 serious adverse events among 5 subjects at risk in each group, and other adverse events affecting 5 of 5 in each group. The record does not give event descriptions or report deaths. These observations are descriptive and do not support broad conclusions about safety, especially in groups of this size.
General: A trial’s design identifies the question its investigators intended to address; conclusions depend on the outcomes actually observed and the analyses reported. In this case, the registry record describes the question and design, but does not provide the primary endpoint results needed to determine what the data show about the treatment comparison.
13. Why This Trial Matters Statistically
This study is statistically notable because the distance between enrollment and endpoint completion is central to understanding what its record can support. The registry reports 11 randomized subjects and 10 who received at least one dose, while only 2 completed the baseline and follow-up BAL and allergen challenge procedures. The endpoint population description identifies 1 completer in each treatment group. Readers need these counts to distinguish the intended study population from the participants contributing the specified primary measurements.
The study also illustrates why an endpoint title is not a result. The primary outcome identifies a biological measurement, its assay, units, and timing, but the record does not report numerical values, an estimate of a treatment-group difference, or a statistical analysis. Without those elements, the central comparison cannot be judged for direction or precision. A planned outcome and a randomized design do not by themselves supply evidence about the measured effect.
The distinction between descriptive safety counts and comparative inference matters as well. The registry reports zero serious adverse events in each group and other adverse events in all 5 subjects at risk in each group. With no event details and few subjects, those counts provide a narrow record of observed safety outcomes rather than a comprehensive comparison.
Finally, the record’s planning assumptions are not a substitute for a reported study-design justification. The assumptions describe an illustration based on an observed effect, but the record does not report the original sample-size justification or a primary comparison to anchor such planning. General: Statistical interpretation depends not only on a design label, but on complete outcome reporting, transparent analysis methods, and clear accounting of missing observations. This record makes those distinctions especially visible.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation specific to this study record is the small number of subjects completing the primary endpoint procedures: 2, with 1 in each treatment group. Although enrollment was 11 and 10 subjects received at least one dose, the registry does not report numerical IL-9 measurements from the endpoint population. It is therefore not possible to assess the distribution of values, the size of a treatment-group difference, or its uncertainty.
The reason for termination is not reported in the registry record. Nor does the record explain why only 2 subjects completed the baseline and follow-up BAL and segmental allergen challenge procedures. Without those explanations, it is not possible to determine whether the incomplete endpoint data arose from a particular operational, participant, or other circumstance.
The registry record does not report the statistical analysis plan, the method used for the primary endpoint, handling of missing measurements, or the analysis populations. It lists multiple outcomes and timing points but does not report a multiplicity strategy or reduce the primary endpoint to one comparison. The absence of analysis records also means there is no reported primary estimate or test to interpret.
Safety reporting is limited to summary counts. Event descriptions, severity, timing, attribution, and deaths are not reported in the registry record. The record also does not provide further participant characteristics or details about randomization sequence generation and masking procedures. These limitations restrict both the statistical and clinical interpretation of the study; they do not reveal the unreported reasons or outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528 — NCT00483041.
- Registry record last updated 2014-03-07; status last verified 2014-02.
- Results first posted 2014-03-07.
- 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
NCT00483041 is listed as a randomized, double-blind, parallel-group Phase 2 study, described as Phase2A in its official title. It evaluated a single intravenous infusion of MEDI-528 at 9 mg/kg against a single intravenous placebo infusion in adults with atopic asthma. Enrollment was 11; the study status is terminated. The record lists the study start as 2007-07 and primary completion as 2008-10.
The primary endpoint was total IL-9 counts in BAL fluid, measured by enzyme-linked immunosorbent assay after segmental allergen challenge. The record reports 10 subjects received at least one dose and 2 completed the specified endpoint procedures, with 1 in each group. Numerical IL-9 results and a primary analysis are not reported in the registry record. Serious adverse events affected 0 of 5 subjects at risk in each group; other adverse events affected 5 of 5 in each group. Event details and deaths are not reported.