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 of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212) (NCT01566149), a non-randomized phase 3 study. The primary outcome is Number of Participants With At Least One Adverse Event (AE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01566149 |
| Phase | Phase 3 |
| Condition | Asthma |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 49 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
Adolescents and adults with persistent asthma were the intended study population. The registry describes the Full Analysis Set as participants assigned treatment who received at least one dose of study medication. The posted arm counts for the primary outcome are 24 participants and 25 participants. Further details about participant characteristics or eligibility criteria are not reported in the registry record.
Intervention
The study assessed two strengths of mometasone furoate/formoterol fumarate (MF/F) delivered by metered-dose inhaler. The arm descriptions identify MF/F 200/10 mcg MDI BID and MF/F 400/10 mcg MDI BID, each for 12 weeks. The intervention names elsewhere in the registry record list 100/5 mcg and 200/5 mcg. The record does not explain the difference between these labels.
Comparator
The two treatment arms are presented alongside one another, but this was not a randomized comparison. The registry explicitly cautions that the arms are not a like-for-like control comparison. Consequently, the arm counts should be read as descriptive results for each group, not as an unbiased estimate of the effect of one strength relative to the other.
Primary question
The primary endpoint asks how many participants had at least one adverse event, with events counted through Week 14. The registry defines an adverse event as an unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to that product. The primary endpoint is a count of participants, not a count of all individual events.
3. Trial Design
This completed Phase 3 study is listed as an open-label, non-randomized, parallel study. It enrolled 49 participants and was sponsored by Organon and Co. The registry lists a start date of 2012-03 and a primary completion date of 2012-09. The study’s stated purpose was to assess the safety, tolerability, and effectiveness of two MF/F metered-dose inhaler strengths in adults and adolescents with persistent asthma.
The arm descriptions state that participants received MF/F 200/10 mcg MDI BID or MF/F 400/10 mcg MDI BID for 12 weeks. The primary safety endpoint covers events through Week 14, while a listed secondary outcome is mean change from baseline in forced expiratory volume in 1 second (FEV1) at Week 12. The record lists five outcome measures, but it does not provide a result for the FEV1 outcome in the registry record for this analysis.
The intervention names and arm descriptions use different strength labels: the intervention list gives 100/5 mcg and 200/5 mcg, whereas the arm descriptions give 200/10 mcg and 400/10 mcg. The registry record does not explain how these labels correspond. That ambiguity limits how confidently a reader can describe the administered strengths from the record alone.
Because allocation was non-randomized and masking was absent, treatment assignment was not protected by random allocation, and participants and study personnel were not masked. The registry cautions that the arms are not a like-for-like control comparison. It does not report details of how participants entered either arm, or whether factors influencing assignment were measured or accounted for. The posted group results therefore support descriptive reading, not a causal contrast between the two strengths.
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: Participants who were previously on medium-dose asthma medication were assigned to Mometasone Furoate/Formoterol Fumarate (MF/F) 200/10 mcg Metered Dose Inhaler (MDI) twice daily (BID) and participants who were previously on high-dose asthma medication were assigned to MF/F 400/10 mcg MDI BID.
Overall Study
| Stage | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| STARTED | 24 | 25 |
| COMPLETED | 21 | 23 |
| NOT COMPLETED | 3 | 2 |
Reasons for not completing this period:
| Reason | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|
| Adverse Event | 0 | 1 |
| Non-compliance with study medication | 2 | 0 |
| Protocol Violation | 0 | 1 |
| Withdrawal by Subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.
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 | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID | Total |
|---|---|---|---|---|
| Participants analysed | 24 | 25 | 49 | |
| Age, Continuous | years | 35.4 (SD 14.48) | 41.2 (SD 14.91) | 38.3 (SD 14.84) |
| Sex: Female, Male: Female | Participants | 14 | 12 | 26 |
| Sex: Female, Male: Male | Participants | 10 | 13 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With At Least One Adverse Event (AE), measured over Up to Week 14.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with at least one adverse event (AE), measured through Week 14. An AE is defined in the registry as any unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to that product. This definition means that the endpoint is not restricted to events judged to have been caused by treatment.
The outcome counts participants who experienced one or more events. It does not count the total number of events, distinguish event severity, or by itself establish whether events were treatment-related. A participant with multiple events still contributes as one participant to this endpoint. Separate safety details would be needed to describe event types, timing, duration, seriousness, or attribution.
Counting participants with at least one AE is a commonly understandable way to summarize whether any event was recorded during a specified observation period. It can provide a broad safety description, but it compresses varied experiences into a single yes-or-no measure for each participant. The posted endpoint is therefore useful as a high-level count, while offering limited detail about the nature or burden of events. The registry defines the Full Analysis Set as participants assigned treatment who received at least one dose of study medication; the primary safety counts are reported for the two treatment groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results report at least one AE in 5 of 24 participants in the MF/F 200/10 mcg MDI BID arm and in 8 of 25 participants in the MF/F 400/10 mcg MDI BID arm. These are descriptive participant counts for the study’s follow-up through Week 14. They do not establish that one arm had a higher or lower underlying risk, because the study was non-randomized and the registry warns that the arms are not a like-for-like control comparison.
The primary outcome records whether a participant experienced at least one AE, rather than the total number of events. It does not identify, in the information, how many events each affected participant experienced, what kinds of events occurred, or whether investigators considered them related to study medication. The registry definition explicitly includes events whether or not considered related. Thus, the count should not be described as a count of medication-caused harms.
The registry reports zero participants with a serious adverse event in each arm. That is a reported count for this endpoint and study population; it is not proof that serious events cannot occur or that the two regimens have equivalent safety. Death counts are not reported in the registry record. The serious-event terms list is empty in the record, so event-level descriptions cannot be drawn from that listing.
No inferential analysis is listed in the registry record. In particular, the registry entries available do not report a comparative effect estimate, confidence interval, or hypothesis test for the AE endpoint. Without such information, the posted counts alone do not quantify the uncertainty around an arm-to-arm difference. Even an estimate with an interval would require careful interpretation in light of the non-randomized design.
The study enrolled 49 participants, and the primary outcome is reported for groups of 24 and 25 participants. With groups of this size, each participant’s outcome contributes visibly to the group count; descriptive counts should therefore not be mistaken for precise estimates of event frequency in a broader population. No generalization beyond this study follows automatically from the observed counts. The registry’s listed secondary outcome—mean change from baseline in FEV1 at Week 12—does not have a result in the registry record, so the primary safety findings do not answer an effectiveness question.
9. Statistical Methods Explained
The posted primary outcome is binary at the participant level: each participant either had at least one AE during the specified period or did not. The registry reports the number of participants with an event and the number at risk in each arm. This is a count-based description. It is not an event rate per unit of follow-up time, because the endpoint does not report event totals or person-time.
What does a participant count capture?
General statistical explanation: a binary endpoint reduces each participant’s experience to one of two categories. This makes the outcome easy to define and compare descriptively, but it discards information about repeated events and differences in event type or duration. A participant who experiences one event and a participant who experiences several events both count once for “at least one AE.” The endpoint therefore addresses whether any event was recorded, not the full burden of events.
The registry defines an AE as an unfavorable and unintended sign, symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to that product. The endpoint is consequently broader than an outcome restricted to events judged caused by treatment. The registry record does not provide event-level details in the registry record, such as specific AE types, timing, or investigator assessments of relatedness.
Why does the design matter?
General statistical explanation: random allocation helps balance both measured and unmeasured participant characteristics across treatment groups on average. Without randomization, differences between groups can reflect who received each treatment as well as treatment itself. This is confounding: factors associated with treatment assignment may also be associated with the outcome. The registry labels this study non-randomized and explicitly says the arms are not a like-for-like control comparison. The posted counts should therefore be read as separate group descriptions, not as a causal estimate of the effect of changing strength.
Open-label means masking was absent. General statistical explanation: knowledge of treatment assignment can influence some aspects of care, reporting, or assessment, depending on the outcome and study procedures. The record does not describe procedures that might reduce such influences. The AE endpoint includes events recorded by participants or investigators, but the registry entries do not specify how events were elicited or adjudicated.
How should uncertainty be understood?
General statistical explanation: an estimate describes the observed study data, while a confidence interval communicates the range of values compatible with those data under a statistical model. A wide interval indicates limited precision; it does not mean that every value in the interval is equally likely. No confidence interval or other comparative inferential result for the primary AE endpoint is reported in the registry record. The counts alone therefore do not show the precision of an estimated difference between groups.
For binary data, a formal comparison could use a model or test appropriate to the design and data. However, a statistical test cannot remove confounding created by non-random allocation. Adjustment could address measured variables if they were collected and modeled appropriately, but the record does not report a primary comparative analysis, adjustment variables, or an analysis plan. The registry lists zero analyses. No inferential conclusion should be reconstructed from the counts alone.
What does over-dispersion mean generally?
General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. It can make standard errors too small and uncertainty appear narrower than it is if the model is not adapted. It is especially relevant to some count outcomes when repeated events are analyzed. The primary endpoint counts participants with any AE rather than total events, and the registry record does not report an over-dispersion assessment or a model for event counts. No conclusion about over-dispersion in this trial is possible from the registry entries.
What do the study’s other listed outcomes add?
The record lists mean change from baseline in FEV1 at Week 12 as a secondary outcome, but no FEV1 result is included in the registry record. The record also gives the total number of outcome measures as five. The individual results for the remaining measures are not reported in the registry record. A list of planned or registered outcomes is not itself evidence of the outcomes’ observed values.
The record gives a sample-size-assumption description for planning illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation. Such illustrations are planning calculations, not observed power and not evidence that the original study was designed using those assumptions. The trial’s own sample-size justification is not reported in the registry record. No planning sample-size values are included in the registry record for interpretation.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| MF/F 200/10 mcg MDI BID | 24 | 5 | 20.8% | 7.1% to 42.2% | 9.2% to 40.5% | 9.4% to 40.7% |
| MF/F 400/10 mcg MDI BID | 25 | 8 | 32.0% | 14.9% to 53.5% | 17.2% to 51.6% | 17.2% to 51.8% |
R code and output
arm <- c("MF/F 200/10 mcg MDI BID", "MF/F 400/10 mcg MDI BID")
n <- c(24, 25)
events <- c(5, 8)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM MF/F 200/10 mcg MDI BID 24 5 20.8 7.1 42.2 9.2 40.5 9.4 40.7
ARM MF/F 400/10 mcg MDI BID 25 8 32.0 14.9 53.5 17.2 51.6 17.2 51.811. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures, including the primary endpoint of participants with at least one AE and the secondary outcome of mean change from baseline in FEV1 at Week 12. It reports zero analyses in the registry record. A statistical plan describing how the outcomes were tested, how multiple comparisons were handled, or which outcome analyses were prioritized is not reported in the registry record.
Multiplicity is a general concern when many outcomes or comparisons are examined: the more opportunities there are to identify an apparently unusual result, the more important it is to interpret individual tests in the context of the analysis plan. That concern cannot be evaluated for this trial from the listed outcomes alone. No adjustment for multiple testing should be assumed, and no unreported analysis should be inferred.
The Full Analysis Set is defined as participants assigned treatment who received at least one dose of study medication. The registry does not report further details about exclusions, missing outcome data, withdrawals, or how missing observations were handled. It also does not describe a method for imputing missing values or a sensitivity analysis. These omissions matter because missingness can affect both the group counts and the generalizability of results if it is related to participants’ outcomes or treatment assignment.
The registry’s sample-size justification and original statistical analysis plan are not reported in the registry record. Without those details, it is not possible to assess whether the analysis followed a prespecified approach or whether the study was planned around a particular endpoint contrast.
12. 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 |
|---|---|---|---|
| MF/F 200/10 mcg MDI BID | 0 | 24 | 0.0% |
| MF/F 400/10 mcg MDI BID | 0 | 25 | 0.0% |
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 |
|---|---|
| MF/F 200/10 mcg MDI BID | 5 of 24 |
| MF/F 400/10 mcg MDI BID | 8 of 25 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 3 of 24 | 2 of 25 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 1 of 24 | 2 of 25 |
| Accidental overdose | Injury, poisoning and procedural complications | 1 of 24 | 2 of 25 |
| Cough | Respiratory, thoracic and mediastinal disorders | 0 of 24 | 2 of 25 |
The serious adverse event counts are zero in the MF/F 200/10 mcg MDI BID arm and zero in the MF/F 400/10 mcg MDI BID arm. These are counts of participants with a serious adverse event in the posted results. They are not the same as the primary endpoint, which counts participants with at least one AE of any seriousness.
A zero count means no participant in the reported group was recorded with the endpoint during the reported observation, not that the event is impossible or that the treatment has no serious-event risk. Small study groups provide limited information about uncommon outcomes, and the non-randomized design also limits comparative interpretation. The registry record does not report a comparative estimate or confidence interval for serious adverse events.
The record’s serious-event terms list is empty. The registry entries available do not identify event details beyond the counts. Deaths are not reported in the registry record; a missing death count should not be interpreted as a confirmed zero. These safety figures describe what was recorded in this study and do not, on their own, establish a difference or equivalence between the arms.
13. What the Result Does, and Does Not, Mean
The primary safety result is a descriptive count of participants who experienced at least one AE through Week 14: 5 of 24 in the MF/F 200/10 mcg MDI BID group and 8 of 25 in the MF/F 400/10 mcg MDI BID group. The serious adverse event counts are zero in both groups. Those figures describe the participants and outcomes reported for this completed study.
They do not establish that either strength causes more or fewer AEs than the other. The study was non-randomized, and the registry cautions that the arms are not a like-for-like comparison. Differences in participant characteristics or other aspects of treatment assignment could affect observed outcomes. The registry record does not provide an adjusted comparative analysis, a confidence interval, or a hypothesis test for the primary endpoint.
The endpoint also does not distinguish events considered related to medication from those not considered related. Its definition includes any AE temporally associated with product use, whether or not considered related. Nor does a count of participants with at least one event show the total number of events or their severity and duration. More detailed event-level results would be needed to describe those dimensions.
The study’s stated purpose included safety, tolerability, and effectiveness, but the registry entries available include only the primary AE counts and the listing of an FEV1 secondary outcome. The FEV1 result and other outcome results are not reported in the registry record. The primary safety figures therefore do not answer whether lung function changed or how effectiveness compared across groups.
These results are specific to this study’s reported participants and follow-up. They do not establish what would occur in other populations or over other periods. The registry lists two different sets of strength labels in the intervention names and arm descriptions and does not explain their relationship, adding uncertainty about how to characterize the administered strengths from the record alone.
14. Why This Trial Matters Statistically
This trial illustrates why a reported difference in group counts is not automatically a treatment effect. The study places two groups side by side, but allocation was non-randomized and the registry warns that they are not a like-for-like control comparison. A numerical contrast may be tempting to interpret causally, yet causal interpretation requires a design and analysis that address how participants came to receive each treatment. The registry does not report such an analysis.
It also shows the value of distinguishing an endpoint’s definition from what readers may assume it represents. “At least one AE” is a participant-level indicator, and the registry’s definition does not require an investigator to judge the event treatment-related. The count can describe whether any AE was recorded, but not the total number of events, their specific nature, or their severity. The zero serious-event counts likewise need to be read as observed counts, not as proof of no risk.
Finally, the record demonstrates how incomplete reporting constrains statistical interpretation. It lists five outcome measures and a secondary FEV1 outcome, yet the registry entries available do not include results for those outcomes or inferential analyses. The sample-size justification, missing-data procedures, and multiplicity approach are also not reported in the registry record. Without those details, readers cannot assess the precision of a comparative effect, the handling of missing observations, or how outcome selection shaped interpretation.
Careful reading therefore separates what the registry directly reports—the study design, endpoint definition, group counts, and serious-event counts—from questions the record does not answer. That distinction is central to transparent statistical interpretation.
15. 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 interpreting the primary result is the non-randomized allocation. The registry explicitly cautions that the arms are not a like-for-like control comparison. The counts cannot isolate treatment effects from potential differences between participants assigned to each group, and the record does not report an adjusted comparative analysis or the factors used in assignment.
The study was open-label, with no masking. The registry entries do not describe procedures for collecting or adjudicating AEs, so the possible influence of unmasked reporting or assessment cannot be evaluated. The endpoint is also broad: it includes AEs whether or not considered related to the medicinal product and reduces each participant’s experience to whether at least one event occurred.
The record does not report a confidence interval, hypothesis test, or other inferential comparison for the primary outcome. It does not report the study’s own sample-size justification, missing-data methods, or multiplicity strategy. Although five outcome measures are listed, the registry entries available include no results for the secondary FEV1 outcome or the other outcomes. The registry lists zero analyses.
There is also an unresolved labeling issue: the intervention names give MF/F 100/5 mcg and 200/5 mcg, while the arm descriptions give MF/F 200/10 mcg and 400/10 mcg. The registry record does not explain this difference. Death counts are not reported in the registry record, and the empty serious-event terms list provides no event-level detail. These limitations restrict both clinical description and statistical comparison.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212) — NCT01566149.
- Registry record last updated 2024-05-24; status last verified 2022-02.
- Results first posted 2013-07-29.
- 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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19. Record Summary
This is a completed Phase 3, open-label, non-randomized, parallel study sponsored by Organon and Co. The registry lists 49 enrolled participants, with a start date of 2012-03 and a primary completion date of 2012-09. It concerns MF/F metered-dose inhalers in adolescents and adults with persistent asthma.
The primary endpoint is the number of participants with at least one AE through Week 14. The registry reports counts of 5 of 24 and 8 of 25 in the two arm descriptions, with zero participants recorded with a serious adverse event in each arm. The registry cautions that the groups are not a like-for-like control comparison.
A secondary outcome is mean change from baseline in FEV1 at Week 12, but its result is not reported in the registry record. The record lists five outcome measures and zero analyses. It does not report the sample-size justification, missing-data methods, or multiplicity approach. Intervention strength labels and arm-description strength labels differ, without an explanation in the registry record.