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 on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS) (NCT01397201), a randomized phase 2 study. The primary outcome is Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01397201 |
| Phase | Phase 2 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Participants were aged 12 to 65 years and had asthma inadequately controlled on low dose inhaled corticosteroid therapy. The registry summary describes inadequate control using a decrease in FEV1 in the range 10-25% and an ACQ-6 score greater or equal 1.5 at randomisation.
Intervention
BI 54903 was administered twice daily using a Respimat inhaler. The tested doses were 45.5, 90.9 and 181.8 mcg. The arm descriptions indicate that each BI 54903 dose was paired with a placebo matching the HFA metered dose inhaler.
Comparator
The comparison groups received fluticasone propionate HFA 220 mcg twice daily with a matching Respimat placebo, or placebo matching both inhalers. This double-dummy arrangement used matching inhalers across assigned groups.
Primary question
The primary endpoint was mean change from randomisation baseline to the end of the 8-week treatment period in trough FEV1, measured before dosing and before rescue bronchodilator use. The registry record states that the sponsor terminated the study and that no valid primary or secondary endpoint data were collected or analysed, so it does not establish an endpoint comparison between groups.
The clinical question was whether the listed BI 54903 regimens could be evaluated alongside an active comparator and placebo in participants whose asthma remained inadequately controlled on low dose inhaled corticosteroid therapy. The trial also planned to assess safety. Its design therefore included both comparisons against placebo and a comparison with fluticasone propionate, but planned comparisons are not evidence of observed differences. Because the record reports no valid efficacy endpoint data, the primary question remains unanswered in the posted results. The absence of an endpoint analysis is not evidence that the groups had the same outcomes, nor does it establish that one regimen was better or worse.
3. Trial Design
This was a phase 2, randomised, double-blind, double-dummy, placebo-controlled, parallel-group study. It was designed to compare an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 mcg twice daily, fluticasone propionate HFA 220 mcg twice daily, and placebo. The registry lists an enrollment of 30. The study status is terminated; the registry record attributes termination to a sponsor decision.
In a parallel-group design, participants are assigned to a treatment group and followed in that group rather than crossing between assigned treatments. Random allocation is intended to reduce systematic differences between groups at the point of assignment. Double blinding means that the study was designed to keep treatment assignment masked for participants and relevant study personnel. The double-dummy approach used matching placebo inhalers so that the different inhaler regimens could be compared under a masked design. These design features describe how the comparison was planned; they do not show that the intended comparisons were completed or analysed.
The intervention descriptions distinguish the dose groups by BI 54903 delivered through Respimat, with placebo matching the HFA inhaler. The fluticasone group received active fluticasone through HFA with a matching Respimat placebo. The placebo group received matching placebo through both inhalers. This design included an active comparator as well as a placebo comparator, but the registry record contains no valid primary or secondary endpoint results with which to assess either comparison.
The record lists a study start of 2011-07-01 and a primary completion date of 2011-12-23. It does not report a trial-specific sample-size justification, the details of any interim analyses, or the sequence of planned hypothesis tests. The listed enrollment should not be interpreted as the number with usable data for any endpoint: the record explicitly states that no valid primary or secondary endpoint data were collected and that no such analyses were conducted.
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: All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Overall Study
| Stage | Placebo | BI 54903 45.5µg Bid | BI 54903 90.9 µg Bid | BI 54903 181.8 µg Bid | Fluticasone Propionate 220µg Bid |
|---|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 7 | 5 |
| Treated | 6 | 6 | 5 | 7 | 5 |
| COMPLETED | 1 | 0 | 0 | 2 | 1 |
| NOT COMPLETED | 5 | 6 | 6 | 5 | 4 |
Reasons for not completing this period:
| Reason | Placebo | BI 54903 45.5µg Bid | BI 54903 90.9 µg Bid | BI 54903 181.8 µg Bid | Fluticasone Propionate 220µg Bid |
|---|---|---|---|---|---|
| Not treated | 0 | 0 | 1 | 0 | 0 |
| Not yet defined | 3 | 6 | 5 | 5 | 4 |
| Adverse Event | 2 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
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 patients that were randomised and treated with at least dose of study drug.
| Characteristic | Unit | BI 54903 45.5µg Bid | BI 54903 90.9 µg Bid | BI 54903 181.8 µg Bid | Fluticasone Propionate 220µg Bid | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 5 | 7 | 5 | 6 | 29 | |
| Age, Continuous | Years | 44.7 (SD 16.4) | 48.4 (SD 6.7) | 53.7 (SD 7.8) | 42.6 (SD 18.2) | 47.8 (SD 8.8) | 47.8 (SD 12.0) |
| Sex: Female, Male: Female | Participants | 1 | 3 | 2 | 4 | 5 | 15 |
| Sex: Female, Male: Male | Participants | 5 | 2 | 5 | 1 | 1 | 14 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 1 | 0 | 0 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 | 4 | 7 | 5 | 6 | 27 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 0 | 2 | 1 | 5 |
| Race (NIH/OMB): White | Participants | 5 | 3 | 7 | 3 | 5 | 23 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1), measured over At baseline and at week 8..
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the mean change from randomisation baseline to the end of the 8-week treatment period in trough forced expiratory volume in one second, or FEV1. Trough measurement was defined as pre-dose and pre-rescue bronchodilator. The registry lists the measurement time as baseline and week 8.
FEV1 is the volume of air expelled during the first second of a forced breathing manoeuvre. In general, it is an objective lung-function measure used in respiratory studies to assess airflow. A change from baseline focuses on how the measured value differs from a participant’s starting value over the specified treatment period. A group mean change can describe the average change among participants included in an analysis, while a comparison between groups can estimate whether those average changes differ. Those interpretations require valid collected data and a defined analysis population.
The trough timing is intended to standardise measurement relative to treatment and rescue bronchodilator use. This can make readings more comparable across scheduled assessments, though it does not remove all sources of measurement variation. The endpoint was relevant to the study’s stated objective because it assessed lung function during treatment. However, the registry record reports that no valid data for the primary endpoint were collected and that no primary endpoint analysis was conducted. There is therefore no reported mean change, between-group estimate, or uncertainty measure to interpret.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the intended comparison clearly but does not report an analysed efficacy result. The primary endpoint was change in trough FEV1 from baseline to the end of the 8-week treatment period. The record states that the sponsor terminated the study and that no valid data for primary or secondary endpoints were collected. It also states that no analyses of those endpoints were conducted. Consequently, there is no reported treatment effect estimate, confidence interval, or statistical test for the primary question.
This absence of an estimate is different from a finding of no difference. A result showing no statistically clear difference would still require valid outcome measurements and an analysis; neither is reported for the primary or secondary endpoints. The registry record therefore cannot show whether any assigned group had a greater, smaller, or similar mean change in FEV1. It also cannot establish the precision of a possible difference, because a confidence interval for that difference is not reported.
General statistical context: a confidence interval expresses the uncertainty around an estimated effect under the assumptions of the analysis. A narrow interval can indicate more precise estimation than a wide interval, but an interval is meaningful only when there is an estimate based on usable data. No such primary or secondary endpoint estimate is available in this record.
The enrollment listed in the registry is not a substitute for endpoint results. Enrollment describes the study record, whereas an endpoint analysis depends on valid outcome observations and the analysis population. The record does not report a count of participants with usable primary endpoint data; instead, it explicitly says that valid endpoint data were not collected. It would therefore be inappropriate to treat enrollment as an analysed sample or use it to infer a treatment effect.
The registry does contain adverse-event counts by group. Those safety entries are descriptive counts and do not fill the gap in efficacy outcomes. The serious adverse-event counts are 0 in each listed group, while other adverse-event counts vary across groups. These entries should be read as the recorded safety summaries, not as an efficacy comparison or a substitute for the planned endpoint analyses. The record does not include a statistical safety comparison.
No conclusion about the relative efficacy of BI 54903, fluticasone propionate, and placebo follows from the missing endpoint analyses. Likewise, the termination and absence of valid endpoint data do not demonstrate that the treatments were equivalent or that an effect was absent. They mean that the posted registry information does not support an efficacy estimate for the stated primary question.
9. Statistical Methods Explained
The available record supports an explanation of the planned design and endpoint, but not a reconstruction of an efficacy analysis. It identifies randomisation, masking, a parallel-group model, the primary outcome, and an 8-week treatment period. It does not report endpoint analyses, estimates, confidence intervals, p-values, or the detailed statistical analysis plan.
What does randomisation contribute?
General: randomisation assigns participants to study groups using a chance-based process. Its purpose is to make systematic differences between groups less likely at assignment, so that an outcome comparison can be interpreted as a comparison of the assigned regimens rather than a comparison of groups chosen for different reasons. Randomisation does not guarantee that groups will be identical in every characteristic, and it cannot compensate for absent or invalid outcome data. In this study, the registry identifies the allocation as randomised but does not report allocation concealment details or the method used to generate the sequence. Those details are not reported in the registry record.
What does masking and the double-dummy design mean?
General: masking limits knowledge of assigned treatment and can reduce the influence of expectations on behaviour, reporting, and assessment. A double-dummy design uses matching placebos to accommodate treatment regimens that may use different inhalers or formats. The listed arm descriptions indicate that participants received active treatment through one inhaler and matching placebo through the other, or matching placebos through both. The record identifies the study as double blind, but it does not specify which study roles were masked or describe how the success of masking was assessed. Those details are not reported in the registry record.
How would a change-from-baseline endpoint be interpreted?
General: a change score compares a follow-up measurement with a baseline measurement for each participant, then summarises those changes for a group. Comparing group mean changes can address whether average change differed between assigned regimens. The interpretation depends on valid measurements, a defined analysis population, and a prespecified method for handling observations that are unavailable or unsuitable. The registry names mean change in trough FEV1 as the primary endpoint, but it reports no valid endpoint data and no analysis. There is thus no change estimate to interpret.
Why do confidence intervals and tests matter?
General: an effect estimate describes the size and direction of an observed contrast, while a confidence interval conveys its statistical uncertainty. A hypothesis test evaluates compatibility between data and a specified null hypothesis under the test’s assumptions. These tools answer different questions: an estimate is about magnitude, an interval about precision, and a test about evidence relative to a statistical model. None can be recovered from the listed trial design alone. No primary endpoint estimate, confidence interval, or p-value is reported in the registry record.
What role does the analysis plan play?
General: an analysis plan specifies how outcomes will be summarised and compared, which participants will contribute to each analysis, what covariates or repeated measurements will be used, and how missing or unusable data will be addressed. Prespecification can limit data-driven choices after outcomes are known. The registry record does not report those details for the primary endpoint. It also does not report the statistical model, any covariate adjustment, assumptions about the distribution of outcomes, or a method for handling multiplicity. These methods are not reported in the registry record, and no endpoint analyses were conducted according to the posted information.
How should planning calculations be separated from trial results?
General: sample-size calculations are planning exercises based on assumptions about variability, allocation, significance level, and the effect a study aims to detect. They are not evidence that an effect occurred. Power calculated under design assumptions is also not observed power, which is not a substitute for interpreting an estimated effect and its uncertainty. The registry record does not report a trial-specific sample-size justification. Any planning illustration should therefore be distinguished from the absent efficacy analysis and should not be presented as an observed treatment result.
Because the record reports termination and no valid primary or secondary endpoint data, statistical methods cannot recover a clinical comparison from the trial’s design description. The methods explain how the intended study might have been analysed; they do not supply a result where no endpoint analysis is reported.
10. Multiplicity, Missing Data and Analysis Populations
The trial planned a primary endpoint and several secondary outcomes, including lung-function measures at different visits, peak expiratory flow, rescue medication use, questionnaire scores, and time to withdrawal due to first asthma exacerbation. It also involved comparisons across BI 54903 dose groups, fluticasone propionate, and placebo. Considering multiple outcomes, visits, and treatment comparisons can raise multiplicity concerns: when many statistical tests are conducted, the chance of at least one apparently notable result can increase. General statistical practice may address this through a prespecified testing sequence or an adjustment method, but the choice depends on the study’s objectives and analysis plan.
The registry record does not report a multiplicity strategy or a hierarchy for the planned comparisons. It reports that no primary or secondary endpoint analyses were conducted, so there are no endpoint test results to interpret or adjust. The absence of an adjustment method in the record should not be mistaken for evidence that an adjustment was or was not used in an analysis.
The record states that no valid data for primary and secondary endpoints were collected. It does not describe how missing, invalid, or incomplete endpoint observations would have been handled, nor does it report a sensitivity analysis. Those missing-data methods are not reported in the registry record. The specific analysis populations—such as which participants would be included in each endpoint analysis—are also not reported. The listed enrollment cannot determine the number of participants in an endpoint analysis, particularly when the record explicitly says no valid endpoint data were collected.
General: missing-data methods matter because conclusions can depend on why measurements are unavailable and how the analysis treats them. Without details on the amount, timing, and reasons for missingness, a reader cannot assess whether a particular statistical approach would be appropriate. In this trial record, the lack of valid endpoint data prevents an efficacy analysis rather than merely leaving an otherwise reported estimate with an unclear missing-data method.
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 | 6 | 0.0% |
| BI 54903 45.5µg Bid | 0 | 6 | 0.0% |
| BI 54903 90.9 µg Bid | 0 | 5 | 0.0% |
| BI 54903 181.8 µg Bid | 0 | 7 | 0.0% |
| Fluticasone Propionate 220µg Bid | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 6 |
| BI 54903 45.5µg Bid | 0 of 6 |
| BI 54903 90.9 µg Bid | 0 of 5 |
| BI 54903 181.8 µg Bid | 0 of 7 |
| Fluticasone Propionate 220µg Bid | 0 of 5 |
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 |
|---|---|
| Placebo | 4 of 6 |
| BI 54903 45.5µg Bid | 3 of 6 |
| BI 54903 90.9 µg Bid | 3 of 5 |
| BI 54903 181.8 µg Bid | 3 of 7 |
| Fluticasone Propionate 220µg Bid | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | BI 54903 45.5µg Bid | BI 54903 90.9 µg Bid | BI 54903 181.8 µg Bid | Fluticasone Propionate 220µg Bid |
|---|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | 2 of 6 | 0 of 6 | 0 of 5 | 0 of 7 | 0 of 5 |
| Nasopharyngitis | Infections and infestations | 0 of 6 | 0 of 6 | 0 of 5 | 2 of 7 | 0 of 5 |
| Gastroenteritis viral | Infections and infestations | 0 of 6 | 0 of 6 | 1 of 5 | 1 of 7 | 0 of 5 |
| Upper respiratory tract infection | Infections and infestations | 1 of 6 | 0 of 6 | 1 of 5 | 0 of 7 | 0 of 5 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 0 of 6 | 1 of 5 | 0 of 7 | 0 of 5 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 0 of 6 | 1 of 5 | 0 of 7 | 0 of 5 |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 0 of 6 | 1 of 5 | 0 of 7 | 0 of 5 |
| Nasal septum ulceration | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 1 of 6 | 0 of 5 | 0 of 7 | 0 of 5 |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | 1 of 6 | 0 of 6 | 0 of 5 | 0 of 7 | 0 of 5 |
| Bronchitis | Infections and infestations | 0 of 6 | 0 of 6 | 0 of 5 | 1 of 7 | 0 of 5 |
The registry lists serious and other adverse-event counts by group. For serious adverse events, the recorded number affected is 0 in the Placebo group, 0 in the BI 54903 45.5µg Bid group, 0 in the BI 54903 90.9 µg Bid group, 0 in the BI 54903 181.8 µg Bid group, and 0 in the Fluticasone Propionate 220µg Bid group. The recorded deaths are 0 in each of those groups.
The other adverse-event counts affected are 4 for Placebo, 3 for BI 54903 45.5µg Bid, 3 for BI 54903 90.9 µg Bid, 3 for BI 54903 181.8 µg Bid, and 0 for Fluticasone Propionate 220µg Bid. The registry also lists the number at risk for these summaries by group. These are counts, not rates: no percentages or adjusted comparisons are reported in the record.
General: a count of 0 serious adverse events means that none were recorded in the listed group for this summary. It does not establish that a treatment has no risk, and the counts alone do not compare risks between groups. Interpretation also depends on event definitions, observation time, completeness of reporting, and the number of participants contributing to the safety summary. The registry record does not provide further detail on those points or a statistical comparison of safety outcomes.
12. What the Result Does, and Does Not, Mean
The main statistical meaning of this record is that a randomised, masked comparison was planned, but no valid primary or secondary endpoint results are reported. The primary question concerned change in trough FEV1 from baseline to the end of the 8-week treatment period. Without valid endpoint data and an analysis, there is no estimate of the difference between BI 54903 and placebo, between BI 54903 and fluticasone propionate, or among the assigned groups.
This is not a neutral or negative efficacy finding. A null result would ordinarily refer to an analysis that estimated an effect and found insufficient evidence of a difference under its statistical framework. Here, the registry record says no valid endpoint data were collected and no endpoint analyses were conducted. The data needed to support either an estimated effect or a finding of no clear difference are absent from the posted results.
The record does establish several details about the trial: its phase, randomised parallel-group design, masked double-dummy approach, planned treatment groups, listed enrollment, and the sponsor’s decision to terminate the study. It also lists adverse-event counts. These details describe the conduct and reporting status of the trial; they do not answer the efficacy question.
General: treatment effects are interpreted using estimates and their uncertainty, in the context of the design and the population studied. A study’s intended outcome cannot stand in for its observed outcome. Likewise, a design intended to reduce bias does not guarantee a usable comparison when valid outcome measurements are unavailable.
The findings should therefore be read as an incomplete evidence record for the planned clinical question. They do not establish whether BI 54903 changed FEV1, whether outcomes differed from placebo or fluticasone propionate, or how precise any such difference might have been. They also do not establish equivalence, absence of an effect, or a safety advantage. Conclusions about those questions are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically important as an example of the distinction between a well-described design and an interpretable result. Randomisation, masking, placebo control, and an active comparator define a framework for comparing treatments. Those features are valuable only when valid outcomes are collected and analysed. In this record, the sponsor’s termination decision and the absence of valid primary and secondary endpoint data mean that the planned efficacy comparisons cannot be evaluated.
The record also illustrates why enrollment and analysis sample size are not interchangeable. Enrollment is listed as 30, but the record does not report a usable endpoint analysis population; it states that no valid endpoint data were collected. A reader cannot infer an effect or its precision from enrollment alone.
General: statistical interpretation requires separating the question a study intended to answer from the evidence it actually reports. A primary endpoint can be clearly defined, and comparisons can be carefully planned, while the results remain unavailable. In such cases, the appropriate conclusion is about the limits of the evidence, not about whether the treatment worked.
Multiple dose groups and secondary outcomes also make prespecified analytical decisions relevant. The registry record does not report a multiplicity strategy or detailed analysis plan, and it reports no endpoint analyses. That absence underscores that the design description alone cannot reveal which estimates would have been emphasised, how uncertainty would have been quantified, or how incomplete data would have been handled.
The safety counts remain distinct from the missing efficacy findings. They provide a limited descriptive record, but do not restore the unreported primary comparison. For clinical researchers and biostatisticians, the central lesson is to keep design, data availability, analysis, and inference separate when interpreting a trial record.
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 is stated directly in the registry record: the study was terminated by sponsor decision, no valid primary or secondary endpoint data were collected, and no analyses of those endpoints were conducted. This prevents interpretation of the intended efficacy comparisons and leaves no reported estimate of the primary endpoint.
The record does not explain why the sponsor decided to terminate the study. It does not report the number of participants with valid baseline or follow-up FEV1 measurements, whether any partial endpoint data existed, or the reasons measurements were unavailable or invalid. Those details are not reported in the registry record. The listed enrollment should not be treated as an endpoint analysis population.
Further limitations concern the statistical methods. A trial-specific sample-size justification, the analysis populations, the model for repeated measurements, any covariate adjustments, the missing-data approach, and a multiplicity strategy are not reported in the registry record. The record also does not provide an endpoint estimate, confidence interval, p-value, or sensitivity analysis. Since no endpoint analyses were conducted, the missing methodological detail does not simply qualify a result; it accompanies the absence of an efficacy result.
The safety summaries are counts and do not include a statistical comparison. The registry record does not provide further detail about adverse-event definitions, duration of safety follow-up, or the handling of events. As a result, these counts have limited scope for comparing safety across groups.
These limitations mean that the posted information can describe the planned trial and the reported safety counts, but it cannot establish the size, direction, or precision of an efficacy effect. The record also does not support conclusions about equivalence or absence of treatment effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS) — NCT01397201.
- Registry record last updated 2022-06-23; status last verified 2022-05.
- Results first posted 2022-06-23.
- 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
The registry record describes a phase 2, randomised, double-blind, double-dummy, placebo-controlled, parallel-group asthma study. It planned an 8-week comparison of BI 54903 at doses of 45.5, 90.9 and 181.8 mcg twice daily with fluticasone propionate HFA 220 mcg twice daily and placebo. The listed enrollment is 30, and the study status is terminated.
The primary endpoint was mean change in trough FEV1 from randomisation baseline to the end of treatment. The registry states that the sponsor terminated the study, no valid primary or secondary endpoint data were collected, and no endpoint analyses were conducted. It therefore reports no efficacy estimate for the planned comparisons. Adverse-event counts are listed by group, including 0 serious adverse events and 0 deaths in each group; these descriptive entries do not provide an efficacy result or a statistical safety comparison.