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 Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma (NCT00683449), a randomized phase 2 study. The primary outcome is Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00683449 |
| Phase | Phase 2 |
| Condition | Asthma, Status Asthmaticus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 29 |
| Arms in the primary outcome | 5 |
| Lead sponsor | MediciNova |
| Results posted | Yes |
2. Clinical Question
Population
Adults experiencing an acute exacerbation of asthma were eligible. The registry states that 29 subjects met the study entry criteria, gave written informed consent, and enrolled. The primary outcome analysis was performed on the Intention-to-Treat (ITT) population.
Intervention
Participants were assigned to intravenous MN-221 dose groups as an adjunct to standard therapy. The registry lists dose groups of 240 μg, 450 μg, 1,000-1,080 μg, and 1,995 μg, with the 240 μg infusion described as lasting 15 minutes and the 1,995 μg administration described as taking place over 15 minutes and 25 minutes.
Comparator
The comparator was an intravenous MN-221 placebo infusion. The trial description identifies placebo as being administered for 15 minutes. Both active treatment and placebo were studied as adjuncts to standard therapy.
Primary question
The primary question was how FEV1, expressed as percent of predicted, changed from baseline to Hour 2 after the start of the MN-221 or placebo infusion. Baseline was measured after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each). The registry posts arm-level means and ranges but no formal test of a treatment difference.
This is a question about short-term lung-function change in an acute-care study setting. It is not a question about longer-term asthma control, recurrence, or outcomes after discharge. The registry also lists hospital admission rate during Visit 1 as a secondary outcome, but no secondary outcome results are included in the posted results described in the record.
3. Trial Design
This was a phase II, randomized, modified single-blind, placebo-controlled, dose-escalation study with a parallel-group model. The official title describes intravenous MN-221 given as an adjunct to standard therapy to adults with an acute exacerbation of asthma. The record lists four MN-221 dose groups and a placebo group. Allocation was randomized, and masking was single; further details about who was masked or how masking was maintained are not reported in the registry record.
The study enrolled 29 subjects. The registry lists the trial status as terminated, with a start date of 2008-06 and a primary completion date of 2009-03. The reason for termination is not reported in the registry record. It also does not report the intended enrollment target, the rationale for the dose levels, or whether each planned dose group was opened in a prespecified sequence.
The arm-level primary outcome results are listed for 240 μg MN-221, placebo, 1,000-1,080 μg MN-221, 450 μg MN-221, and 1,995 μg MN-221. The posted group sizes are 5, 13, 3, 6, and 2, respectively. The registry describes the 240 μg infusion as lasting 15 minutes, the placebo infusion as lasting 15 minutes, and the 1,995 μg administration as taking place over 15 minutes and 25 minutes. The administration details for the other groups are not reported in the registry record beyond the dose descriptions.
Standard therapy is named in the study objective, and the primary endpoint description specifies two doses of albuterol and ipratropium before the baseline measurement. Other details about standard therapy, treatment procedures, adherence, or co-interventions are not reported in the registry record. No formal comparative analysis is posted, so the randomized design alone does not supply an estimate of the treatment contrast or its uncertainty.
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: Some subjects were consented for the study, but upon screening, failed to meet the inclusion and exclusion criteria, had an FEV1 \> 50%, or refused to participate.
Overall Study
| Stage | 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | MN-221 Placebo i.v. Infusion | 1,000-1,080 μg MN-221 i.v. | 450 μg MN-221 i.v. for 15 Minutes | 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes |
|---|---|---|---|---|---|
| STARTED | 5 | 13 | 3 | 6 | 2 |
| COMPLETED | 5 | 12 | 3 | 6 | 2 |
| NOT COMPLETED | 0 | 1 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | MN-221 Placebo i.v. Infusion | 1,000-1,080 μg MN-221 i.v. | 450 μg MN-221 i.v. for 15 Minutes | 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes |
|---|---|---|---|---|---|
| Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the 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.
| Characteristic | Unit | 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | MN-221 Placebo i.v. Infusion | 1,000-1,080 μg MN-221 i.v. | 450 μg MN-221 i.v. for 15 Minutes | 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 5 | 13 | 3 | 6 | 2 | 29 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 13 | 3 | 6 | 2 | 29 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age Continuous | years | 30.2 (SD 11.56) | 42.6 (SD 9.7) | 22.3 (SD 3.21) | 39.2 (SD 9.77) | 45 (SD 0.0) | 37.83 (SD 11.31) |
| Sex: Female, Male: Female | Participants | 3 | 7 | 3 | 6 | 2 | 21 |
| Sex: Female, Male: Male | Participants | 2 | 6 | 0 | 0 | 0 | 8 |
| Region of Enrollment: United States | participants | 5 | 13 | 3 | 6 | 2 | 29 |
6. Primary Endpoint
The registry lists the primary outcome as Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo., measured over Baseline and Hour 2.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | FEV1 (percent of predicted) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change from baseline in FEV1 expressed as percent of predicted at Hour 2. FEV1 is the volume of air forcibly exhaled during the first second of a forced breath. Expressing it as percent of predicted relates the measured value to a predicted value; the registry does not give further details about the prediction equation used.
Baseline was defined after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each). The Hour 2 measurement was defined as FEV1 percent of predicted at 2 hours after the start of the MN-221 or placebo infusion. The endpoint therefore concerns change over a specified short interval after those treatments, rather than change from an untreated starting measurement.
FEV1 is used as a measure of airflow limitation. A change score places the follow-up value in relation to the participant’s baseline value, which can help describe whether lung function moved upward or downward during the study interval. In the posted results, each group is summarized by a mean change and a full range. The record does not provide participant-level measurements, an estimate of the between-group difference, a confidence interval for that difference, or a statistical test. Those omissions limit how precisely the results can answer whether the groups differed.
The endpoint is distinct from the secondary outcome described as FEV1 in liters, and from hospital admission rate during Visit 1. Results for those secondary outcomes are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is a set of arm-level summaries, not a formal comparison between MN-221 and placebo. The mean change in FEV1 percent of predicted was 16.57 in the 240 μg group, 3.88 in the placebo group, 3.03 in the 1,000-1,080 μg group, 4.27 in the 450 μg group, and -0.82 in the 1,995 μg group. These means describe the observed change within each group. They do not, by themselves, quantify the uncertainty in a treatment-versus-placebo effect.
The full ranges were 4.8 to 44.7 for 240 μg, -13.2 to 19.9 for placebo, -0.4 to 6.0 for 1,000-1,080 μg, -3.3 to 11.9 for 450 μg, and -2.4 to 0.8 for 1,995 μg. A range describes the lowest and highest reported values, not the precision of the mean or the range of plausible treatment effects. The ranges include both positive and negative changes in several groups. The registry does not report confidence intervals for the group means or for between-group contrasts.
The observed arm means vary across the dose groups, but these data do not establish a dose-response pattern. The group sizes are small, and the registry reports no formal analysis that adjusts for sampling variation or compares each dose group with placebo. The range of values also indicates that individual changes varied within groups. Without a model-based estimate and uncertainty interval, it is not possible to determine from these summaries how much of the apparent variation reflects treatment differences rather than chance or differences among participants.
The record identifies the primary analysis population as ITT and describes the outcome as summarized by treatment group. It does not provide analysis details such as the number contributing endpoint data in each group, how missing measurements were handled, or whether any adjustment was made. No p-value, confidence interval, or other inferential result is reported in the registry record. Consequently, the posted numbers support descriptive interpretation of the enrolled groups, not a conclusion about statistical significance.
The record also reports safety counts by group, including serious adverse events and other adverse events. These figures are useful as descriptions of events recorded during the study, but the registry does not provide a causal attribution analysis or enough context to compare risks reliably. The study’s terminated status does not establish why it ended or whether the termination was related to efficacy, safety, recruitment, or another reason; the reason is not reported in the registry record.
9. Statistical Methods Explained
What does a mean change describe?
A mean change is the average of participants’ follow-up values after accounting for their baseline values. For this endpoint, each change is expressed in FEV1 percent of predicted, with the follow-up measurement taken at Hour 2. A positive mean indicates that the group’s average change was upward from baseline; a negative mean indicates a downward average change. The mean compresses the group’s observations into one summary, so it does not show how every participant changed. The registry reports the mean for each arm, but it does not post participant-level results.
The mean is a descriptive statistic, not a treatment-effect estimate by itself. In a randomized trial, a treatment effect is generally expressed as a contrast between groups, such as a difference in mean change between an active-treatment group and the placebo group. The registry record does not report those contrasts or their uncertainty. A reader should therefore distinguish the arm-specific mean changes from evidence about whether groups differ.
What does the full range tell us?
The full range gives the lowest and highest observed values in a group. It can convey how widely the observed outcomes span, and whether the group includes changes in different directions. It is sensitive to extreme observations and becomes wider or narrower depending on the values in the group. It is not a confidence interval, and it does not indicate how precisely the group mean has been estimated.
The record identifies the dispersion as “Full Range.” It also lists values of 11.17 for the 240 μg group and 7.79 for placebo, but does not identify those values as a particular dispersion measure in this discussion of the endpoint description. The corresponding dispersion entries for the other three MN-221 groups are not reported in the registry record. They should not be treated as standard deviations or standard errors without an explicit definition.
Why are confidence intervals useful?
General statistical explanation: a confidence interval is an interval estimate that expresses the uncertainty around an estimated quantity under a statistical method. For a treatment comparison, an interval can show which effect sizes remain compatible with the data and the assumptions used to calculate it. Its width reflects precision: wider intervals indicate less precision than narrower intervals. A confidence interval is not the same thing as the observed range of individual outcomes.
No confidence interval for the primary treatment comparison is reported in the registry record. Without one, readers cannot assess the precision of a posted between-group effect because no such effect estimate is posted. A p-value is also not reported, and neither a p-value nor a confidence interval should be inferred from the arm means and ranges alone.
What do small groups mean for interpretation?
General statistical explanation: estimates based on small groups can be sensitive to the outcomes of individual participants. Small groups also tend to yield less precise estimates than larger groups, all else being equal. This matters for both the observed means and estimates of variability. The posted group sizes are 5, 13, 3, 6, and 2, so the mean and range in each group summarize a limited number of observations. The registry does not report a precision estimate that would quantify this uncertainty.
What is over-dispersion?
General statistical explanation: over-dispersion occurs when observed variability in data is greater than a model assumes. It matters because a model that underestimates variability may give confidence intervals that are too narrow and tests that are too optimistic. It is most directly relevant to outcomes modeled as counts or rates, rather than a continuous FEV1 change score. The registry does not report a model for the primary endpoint or a diagnostic assessment of over-dispersion. No conclusion about over-dispersion in this study can be drawn from the posted summaries.
How should planning calculations be read?
Any accompanying sample-size calculations are planning illustrations based on the observed effect, not the trial’s original design and not observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. Such calculations ask how many participants per arm a future study might plan for under those assumptions. They do not establish that the present trial had adequate power, and they do not convert a descriptive result into evidence of a treatment effect.
The registry record does not report the trial’s own sample-size justification, planned power, or assumptions for its design. No claim about the study’s intended statistical power or the reason for its enrollment target can be made from the posted record.
10. Multiplicity, Missing Data and Analysis Populations
The registry describes one primary efficacy outcome: change from baseline in FEV1 percent of predicted at Hour 2. It also lists two secondary outcomes: FEV1 in liters and hospital admission rate during Visit 1. Although the record indicates three outcome measures overall, results for the two secondary outcomes are not reported in the registry record. The record also reports no analyses. It does not identify a hierarchy for testing outcomes, a multiplicity adjustment, or a strategy for controlling the chance of false-positive findings across outcomes or dose-group comparisons. These matters are not reported in the registry record.
The primary analysis population is identified as ITT. The registry states that the analysis was performed on this population and that 29 subjects met the study entry criteria, provided written informed consent, and enrolled. It does not report the number contributing primary outcome data in each arm, the number with missing endpoint measurements, or how missing data were handled. It is therefore not possible to determine from the registry record whether all enrolled subjects contributed to the posted arm summaries or what assumptions underlie any exclusions or missing measurements.
General statistical explanation: missing outcome data can affect interpretation because the observed participants may not represent all randomized participants. Methods for handling missing data rely on assumptions about why measurements are missing and how missing outcomes relate to observed data. Since the registry does not report a missing-data method or the extent of missingness, the consequences for the primary outcome cannot be assessed from the posted information.
The record does not describe interim analyses, stopping rules, or a prespecified statistical analysis plan. These details are not reported in the registry record, so no assumptions should be made about them.
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 |
|---|---|---|---|
| 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | 0 | 5 | 0.0% |
| MN-221 Placebo i.v. Infusion | 4 | 13 | 30.8% |
| 1,000-1,080 μg MN-221 i.v. | 0 | 3 | 0.0% |
| 450 μg MN-221 i.v. for 15 Minutes | 1 | 6 | 16.7% |
| 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes | 1 | 2 | 50.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | 3 of 5 |
| MN-221 Placebo i.v. Infusion | 6 of 13 |
| 1,000-1,080 μg MN-221 i.v. | 0 of 3 |
| 450 μg MN-221 i.v. for 15 Minutes | 1 of 6 |
| 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes | 2 of 2 |
Most frequent serious adverse event terms
| Event term | Organ system | 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | MN-221 Placebo i.v. Infusion | 1,000-1,080 μg MN-221 i.v. | 450 μg MN-221 i.v. for 15 Minutes | 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes |
|---|---|---|---|---|---|---|
| Exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | 0 of 5 | 4 of 13 | 0 of 3 | 1 of 6 | 1 of 2 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 0 of 5 | 1 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes | MN-221 Placebo i.v. Infusion | 1,000-1,080 μg MN-221 i.v. | 450 μg MN-221 i.v. for 15 Minutes | 1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes |
|---|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | 3 of 5 | 6 of 13 | 0 of 3 | 1 of 6 | 2 of 2 |
| Blood lactic acid increased | Investigations | 2 of 5 | 1 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
| Blood potassium decreased | Investigations | 3 of 5 | 0 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
| Lymphocyte count decreased | Investigations | 2 of 5 | 0 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
| Monocyte count decreased | Blood and lymphatic system disorders | 2 of 5 | 0 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
| Pneumonia | Infections and infestations | 0 of 5 | 1 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
| Blood bicarbonate decreased | Investigations | 1 of 5 | 0 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
| Abdominal Distention | Gastrointestinal disorders | 0 of 5 | 0 of 13 | 0 of 3 | 1 of 6 | 0 of 2 |
| Abdominal Pain | Gastrointestinal disorders | 0 of 5 | 0 of 13 | 0 of 3 | 1 of 6 | 0 of 2 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 5 | 1 of 13 | 0 of 3 | 0 of 6 | 0 of 2 |
Serious events with the highest arm-level rate: exacerbation of asthma (50.0%), pneumonia (7.7%).
The registry lists serious adverse events and other adverse events by group. For serious adverse events, the at-risk and affected counts are 5 and 0 for 240 μg MN-221; 13 and 4 for placebo; 3 and 0 for 1,000-1,080 μg MN-221; 6 and 1 for 450 μg MN-221; and 2 and 1 for 1,995 μg MN-221. For other adverse events, the corresponding at-risk and affected counts are 5 and 3; 13 and 6; 3 and 0; 6 and 1; and 2 and 2.
These are counts as recorded in the registry, not adjusted comparisons of safety between groups. The record does not report whether events were judged related to study treatment, how event severity was graded, or the criteria used to classify an event as serious. It also does not provide the timing or duration of events. A count of affected participants should not be interpreted as evidence that the study treatment caused an event.
The registry lists “Exacerbation of asthma” at 50.0% and “Pneumonia” at 7.7% among the top serious-event terms. The denominator and event-count context for these percentages are not reported in the registry record. Deaths are listed as null for each group; this means death counts are not reported in the registry record, rather than establishing that no deaths occurred.
12. What the Result Does, and Does Not, Mean
The posted results describe short-term changes in FEV1 percent of predicted across five randomized groups. The largest posted mean change was 16.57 in the 240 μg MN-221 group; the placebo mean change was 3.88. The other MN-221 group means were 3.03, 4.27, and -0.82. The full ranges show that observed changes varied within groups, and several groups include both negative and positive values.
These summaries do not establish that MN-221 caused a change, that one dose was better than another, or that an observed difference would be reproducible. The registry does not report a formal treatment comparison, confidence interval, p-value, or analysis details that would support such conclusions. The dose groups also have small posted group sizes, so their descriptive estimates should be read with caution. A treatment-effect estimate and an uncertainty interval would be needed to assess the magnitude and precision of a contrast with placebo.
The results concern the defined FEV1 measurement at Hour 2 after the start of infusion, with baseline measured after albuterol and ipratropium. They do not address longer-term lung function, sustained symptom control, later asthma exacerbations, or outcomes beyond the study visit. Although hospital admission rate during Visit 1 is listed as a secondary outcome, its results are not reported in the registry record.
The safety counts describe recorded serious and other adverse events in the groups. They do not determine whether an event was caused by MN-221, and the registry does not report a comparative safety analysis. The study is marked terminated, but the reason is not reported in the registry record. The termination status alone does not explain the findings or establish why the study stopped.
Overall, the record offers descriptive efficacy and safety information from a small phase II trial, but it does not provide the inferential analyses needed to estimate comparative effects precisely. Its results are best understood as arm-level observations rather than a definitive assessment of benefit or harm.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between reporting outcomes by arm and estimating a randomized treatment contrast. The registry posts means and full ranges for each group, which describe what was observed within those groups. However, randomized clinical questions concern differences between assigned groups. Without a reported contrast and its uncertainty, the descriptive summaries cannot establish the size or precision of a treatment effect.
The dose-escalation structure also highlights a common challenge in early-phase studies: several treatment groups may be evaluated while each has a limited number of participants. In this record, the posted group sizes are 5, 13, 3, 6, and 2. Estimates based on such groups can be unstable, and apparent differences across doses may reflect sampling variation. A formal dose-response analysis is not reported in the registry record.
The endpoint definition matters as well. The baseline measurement followed two doses of albuterol and ipratropium, and the follow-up measurement was taken at Hour 2 after infusion began. That context is essential to understanding what the change score represents. The posted outcome is not a generic measure of asthma status; it is a specific short-term lung-function measure under the study’s stated treatment conditions.
Finally, this record shows why transparent reporting of analysis methods, missing data, and outcome results matters. The registry identifies the ITT population but does not describe missing-data handling, multiplicity procedures, or formal statistical analyses. These details affect how confidently descriptive results can be translated into conclusions. The record therefore provides a useful example of both the information available from arm-level reporting and the limits imposed when comparative estimates and their uncertainty are absent.
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 primary outcome results are descriptive, and the registry reports no formal between-group estimates, confidence intervals, p-values, or analysis results. This prevents assessment of the precision of any apparent difference between MN-221 and placebo. The group sizes are small, and the ranges are not substitutes for uncertainty intervals around a treatment comparison.
The registry record does not report the reason for termination, the planned enrollment target, a sample-size justification, or the trial’s original statistical plan. It also does not report details of randomization implementation, allocation concealment, or which parties were masked under the modified single-blind design. The meaning of “modified” is not explained in the registry record.
Although the primary analysis is identified as ITT, the record does not state how many participants contributed endpoint data in each arm or how missing measurements were managed. It does not report multiplicity procedures for the several dose groups and outcomes. The secondary outcomes are listed, but their results are not reported in the registry record.
The primary endpoint uses FEV1 percent of predicted, but the prediction method is not reported in the registry record. The posted dispersion information is incomplete across groups, and the record does not identify the nature of the additional listed dispersion values. The safety results also lack information about event relatedness, severity grading, timing, and the denominator for the listed serious-event percentages. These reporting gaps limit interpretation of both efficacy and safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma — NCT00683449.
- Registry record last updated 2011-10-07; status last verified 2011-10.
- Results first posted 2011-07-29.
- 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
NCT00683449 is a randomized, modified single-blind, placebo-controlled phase II parallel-group dose-escalation study of intravenous MN-221 as an adjunct to standard therapy in adults experiencing an acute exacerbation of asthma. The registry lists 29 enrolled subjects, a start date of 2008-06, a primary completion date of 2009-03, and a status of terminated.
The primary outcome was change from baseline in FEV1 percent of predicted at Hour 2 after infusion began. The registry posts means and full ranges by dose group and placebo, along with serious and other adverse-event counts. The primary analysis population is identified as ITT. Formal comparative analyses, confidence intervals, p-values, missing-data methods, and the reason for termination are not reported in the registry record. Results for the listed secondary outcomes are also not reported in the registry record.