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 Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™) (NCT05865886), a randomized phase 2 study. The primary outcome is Occurrence of Any Treatment Emergent Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05865886 |
| Phase | Phase 2 |
| Condition | Cystic Fibrosis, Bronchiectasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 22 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 18 years and older with cystic fibrosis bronchiectasis were eligible. The registry lists cystic fibrosis and bronchiectasis as the conditions studied. The primary outcome population was the Treated Set: randomized patients documented to have taken at least one dose of investigational treatment. The registry reports enrollment of 22, while the posted treated-set group sizes are 7 for placebo and 15 for BI 1291583 5 mg. These figures describe different aspects of the record and should not be treated as interchangeable.
Intervention
Participants assigned to the active-treatment group took BI 1291583 tablets, described in the arm listing as 5 mg BI 1291583. The study description states that participants took one tablet once daily for 12 weeks. The trial evaluated safety, tolerability, pharmacodynamics and pharmacokinetics; the primary outcome focused on treatment-emergent adverse events rather than a measure of clinical benefit.
Comparator
The comparator was placebo, described as tablets that look like BI 1291583 tablets but do not contain medicine. Participants in both groups followed the once-daily tablet schedule for 12 weeks. The study description says participants had twice the chance of assignment to BI 1291583 as to placebo. The registry identifies the trial as randomized, double-blind and placebo-controlled.
Primary question
The primary question was how often participants experienced any treatment-emergent adverse event during the specified observation period: from the first dose through the last dose, plus 28 days of residual effect period, up to 16 weeks. The registry expresses this outcome as a percentage of participants. The posted percentages are 85.7% for placebo and 93.3% for BI 1291583 5 mg. Those descriptive values alone do not establish whether the groups differ beyond what could occur by chance, nor do they determine the clinical importance of any difference.
3. Trial Design
Clairafly™ (NCT05865886) is a randomized, quadruple-masked, parallel-group phase 2 trial sponsored by Boehringer Ingelheim. It compared BI 1291583 with placebo in adults with cystic fibrosis bronchiectasis. The registry describes a double-blind, placebo-controlled study in its official title; its design fields also identify quadruple masking. These descriptions indicate that masking was part of the design, but the registry record does not identify which roles were included in the quadruple masking.
Participants were assigned to one of two groups. The study description says assignment was random and that the chance of assignment to BI 1291583 was twice the chance of assignment to placebo. Both groups took one tablet once daily for 12 weeks. Participants were in the study for about 6 months and visited the study site 7 times, where doctors checked their health and recorded health problems that could have been caused by BI 1291583. The registry lists enrollment of 22. The posted treated-set group sizes are 15 for BI 1291583 5 mg and 7 for placebo; the analysis population includes randomized patients documented to have taken at least one dose.
The primary outcome was occurrence of any treatment-emergent adverse event. Secondary outcomes included sputum neutrophil elastase activity and pharmacokinetic measures of BI 1291583 in plasma after the first dose and at steady state. The registry lists 5 secondary outcomes and 6 outcome measures. The trial is marked completed, with a start date of 2024-04-05 and primary completion date of 2024-10-07. These design details describe the conduct and scope of the study; they do not by themselves establish a treatment effect.
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 | 5 mg BI 1291583 |
|---|---|---|
| STARTED | 7 | 15 |
| COMPLETED | 7 | 14 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Placebo | 5 mg BI 1291583 |
|---|---|---|
| Serious adverse event | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
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: Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
| Characteristic | Unit | Placebo | 5 mg BI 1291583 | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 15 | 22 | |
| Age, Continuous | years | 32.4 (SD 9.4) | 32.3 (SD 11.0) | 32.4 (SD 10.3) |
| Sex: Female, Male: Female | Participants | 4 | 5 | 9 |
| Sex: Female, Male: Male | Participants | 3 | 10 | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 14 | 21 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 7 | 15 | 22 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Occurrence of Any Treatment Emergent Adverse Events, measured over From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint measures whether a participant experienced any treatment-emergent adverse event. The registry expresses it as a percentage of participants in the Treated Set who had such an event. The observation period began with the first dose of trial drug and extended through the last dose, with a 28-day residual effect period, up to 16 weeks. The Treated Set includes randomized patients documented to have taken at least one dose of investigational treatment.
An endpoint based on any event provides a broad summary of recorded safety experience during the specified period. It can capture whether participants experienced at least one event, but it does not describe the event’s severity, duration, recurrence, or relationship to treatment. Those aspects require separate information. The registry also reports serious adverse-event figures, which should be read separately from the broad primary endpoint rather than assumed to represent the same outcome definition.
Safety and tolerability outcomes are used in a trial such as this to characterize the types and frequency of health problems observed while participants receive study treatment or placebo. The posted primary percentages are 85.7% for placebo and 93.3% for BI 1291583 5 mg. These percentages are descriptive. The registry record does not report an inferential comparison, confidence interval, or adjusted effect estimate for this endpoint. Without those quantities, the precision of the between-group contrast cannot be assessed from the posted primary results alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports that any treatment-emergent adverse event occurred in 85.7% of the placebo group and 93.3% of the BI 1291583 5 mg group. These are percentages in the Treated Set, whose posted group sizes are 7 and 15, respectively. The percentages describe the observed groups during the primary endpoint’s specified period. They do not, by themselves, show how precisely the underlying event rates have been estimated.
The group sizes are small, so each participant’s outcome can have a substantial influence on a percentage. This makes the descriptive figures particularly sensitive to individual observations. A numerical separation between the percentages should therefore be read alongside uncertainty, not as a definitive estimate of a reproducible difference. The registry record does not report a confidence interval or a formal statistical comparison for the primary endpoint. It also lists no posted analysis entries. Consequently, the record does not establish whether a statistical test was performed or what its result would be.
The primary endpoint combines all treatment-emergent adverse events into a broad indicator. It does not distinguish mild from severe events or summarize how long events lasted. Serious adverse events are reported separately: 1 participant in the placebo group and 5 participants in the BI 1291583 group were affected, with 0 deaths reported in either group. These counts answer a different question from the percentage experiencing any treatment-emergent adverse event. Seriousness, event type, and the overall any-event measure should not be conflated.
The registry also lists serious-event terms with percentages: infective pulmonary exacerbation of cystic fibrosis, 20.0%; infective exacerbation of bronchiectasis, 14.3%; hepatic cirrhosis, 6.7%; and seizure, 6.7%. The record does not give a denominator alongside each term in that listing, so the percentages should be quoted as recorded rather than converted into counts or attributed to a specific group without further information. The listed terms do not establish causality.
These results are best understood as descriptive safety observations from a completed phase 2 trial, not as a precise estimate of comparative risk. The registry record does not report an inferential analysis for the primary endpoint, a confidence interval, or a statistical plan. It also does not report enough detail to determine how any missing outcome data were handled. Those omissions limit how far the posted percentages can support conclusions about the contrast between groups.
9. Statistical Methods Explained
For a binary endpoint, each participant is classified according to whether the event occurred during the defined period. The registry’s primary measure is the percentage of participants with any treatment-emergent adverse event. This is a descriptive summary: it reports the observed proportion in each group rather than directly expressing uncertainty about the difference between groups.
What does a confidence interval add?
As a general statistical explanation, a confidence interval describes uncertainty around an estimate using a range of values compatible with the observed data and the method used. It helps readers distinguish a point estimate from the range of plausible underlying effects. For a comparison of event percentages, an interval around the contrast would help show how much uncertainty remains. The registry record does not report a confidence interval for the primary endpoint, so its precision cannot be read from the posted percentages alone.
Why do group sizes matter?
As a general principle, estimates based on fewer participants tend to be less precise than estimates based on more participants, all else being equal. In small groups, a change in the outcome status of a single participant can noticeably change the observed percentage. The treated-set group sizes recorded for this trial are 7 for placebo and 15 for BI 1291583 5 mg. Those sizes are important context when interpreting the displayed percentages, but they do not justify calculating a new effect estimate or uncertainty measure without an analysis method and the required information.
What does randomization contribute?
As a general concept, random assignment aims to reduce systematic differences between groups at the start of a trial. It does not guarantee that groups will be identical, especially in a small study, and it does not remove uncertainty from the results. The registry identifies this study as randomized and parallel-group. It also says the chance of assignment to BI 1291583 was twice the chance of assignment to placebo. The posted allocation counts describe who was in the Treated Set, not necessarily every detail of the randomization process.
How should the event percentage be understood?
The endpoint counts whether a participant experienced any treatment-emergent adverse event in the specified period. A participant with multiple events still contributes to the broad endpoint as a participant who experienced an event; the percentage is not a count of all individual events. This distinction matters because event frequency and the number of participants affected are different summaries. The registry’s endpoint definition and percentage format support an interpretation as participants affected, not total event episodes.
Why separate the primary endpoint from serious events?
The primary endpoint covers any treatment-emergent adverse event, while the serious-event figures concern events classified as serious in the registry. These summaries have different scopes. Serious-event counts can provide information about an important subset of events, but they do not replace the broader endpoint. The record reports 1 affected participant in the placebo group and 5 in the BI 1291583 group for serious adverse events, and 0 deaths in both groups. The registry’s serious-event terms and percentages should be interpreted with the denominator and event definitions in mind; those details are not fully reported alongside every listed term.
What can be said about statistical testing?
The record lists 0 analyses. It does not report a test statistic, p-value, confidence interval, or adjusted comparison for the primary endpoint. A p-value, as a general concept, assesses how compatible observed data are with a specified null model under the assumptions of a test; it is not a measure of clinical importance or the probability that a treatment works. Without a reported analysis, readers should not infer statistical significance from the difference between the two posted percentages.
What about planning calculations?
Sample-size calculations are planning illustrations rather than evidence about what the trial observed. The stated planning framework uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and a target effect defined as a fraction of the observed effect. However, the record indicates that values are missing or not estimable for a two-arm comparison for this binary percentage endpoint. Accordingly, no numerical planning result should be inferred from the primary outcome. Any planning illustration, when estimable, would not be observed power and would depend on its assumptions. The registry record does not report the trial’s own sample-size justification or a statistical analysis plan.
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 |
|---|---|---|---|---|---|---|
| Placebo | 7 | 6 | 85.7% | 42.1% to 99.6% | 48.7% to 97.4% | 47.3% to 96.8% |
| BI 1291583 5 mg | 15 | 14 | 93.3% | 68.1% to 99.8% | 70.2% to 98.8% | 69.8% to 98.4% |
R code and output
arm <- c("Placebo", "BI 1291583 5 mg")
n <- c(7, 15)
events <- c(6, 14)
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 Placebo 7 6 85.7 42.1 99.6 48.7 97.4 47.3 96.8
ARM BI 1291583 5 mg 15 14 93.3 68.1 99.8 70.2 98.8 69.8 98.411. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 secondary outcomes alongside the primary endpoint. These include relative change in sputum neutrophil elastase activity at Week 8 and pharmacokinetic measures of BI 1291583 in plasma after the first dose and at steady state. Considering multiple outcomes can raise the chance of a false-positive finding when many statistical tests are conducted. As a general matter, trial analyses may address this through a prespecified hierarchy or an adjustment procedure. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or an inferential analysis of the secondary outcomes. Therefore, no claim about adjustment or confirmatory status can be made from the record.
The record lists 0 analyses. It does not describe how missing outcome values were handled, whether any participants had missing endpoint data, or whether sensitivity analyses were conducted. The primary population is the Treated Set, defined as randomized patients documented to have taken at least one dose of investigational treatment. That definition identifies who was included in the stated population, but it does not explain the handling of missing observations or establish an intention-to-treat analysis.
The registry lists enrollment of 22 and reports treated-set group sizes of 7 for placebo and 15 for BI 1291583 5 mg. The record does not report a participant flow account explaining whether any randomized participants were excluded from the Treated Set or why. It also does not report a statistical analysis plan or the method used for any unposted analyses. These missing details limit assessment of possible bias and the reproducibility of an inferential comparison.
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 |
|---|---|---|---|
| Placebo | 1 | 7 | 14.3% |
| 5 mg BI 1291583 | 5 | 15 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 7 |
| 5 mg BI 1291583 | 0 of 15 |
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 | 6 of 7 |
| 5 mg BI 1291583 | 13 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | 5 mg BI 1291583 |
|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | 0 of 7 | 3 of 15 |
| Infective exacerbation of bronchiectasis | Infections and infestations | 1 of 7 | 1 of 15 |
| Hepatic cirrhosis | Hepatobiliary disorders | 0 of 7 | 1 of 15 |
| Seizure | Nervous system disorders | 0 of 7 | 1 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | 5 mg BI 1291583 |
|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | 1 of 7 | 4 of 15 |
| Headache | Nervous system disorders | 1 of 7 | 2 of 15 |
| Diarrhoea | Gastrointestinal disorders | 2 of 7 | 0 of 15 |
| Nasopharyngitis | Infections and infestations | 0 of 7 | 2 of 15 |
| Forced expiratory volume decreased | Investigations | 0 of 7 | 2 of 15 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 2 of 7 | 0 of 15 |
| Skin exfoliation | Skin and subcutaneous tissue disorders | 0 of 7 | 2 of 15 |
| Anaemia | Blood and lymphatic system disorders | 1 of 7 | 0 of 15 |
| Splenomegaly | Blood and lymphatic system disorders | 0 of 7 | 1 of 15 |
| Tachycardia | Cardiac disorders | 0 of 7 | 1 of 15 |
Serious events with the highest arm-level rate: infective pulmonary exacerbation of cystic fibrosis (20.0%), infective exacerbation of bronchiectasis (14.3%), hepatic cirrhosis (6.7%), seizure (6.7%).
The serious adverse-event figures report 1 affected participant among the placebo group and 5 among the BI 1291583 group. The record reports 0 deaths in each group. These are participant counts for serious adverse events, not the primary endpoint percentages for any treatment-emergent adverse event. The two outcomes have different definitions and should be kept separate.
The registry lists serious-event terms and percentages: infective pulmonary exacerbation of cystic fibrosis at 20.0%, infective exacerbation of bronchiectasis at 14.3%, hepatic cirrhosis at 6.7%, and seizure at 6.7%. The listing does not state a denominator alongside each percentage. It also does not establish whether a term occurred in one or both groups, or whether categories overlap. For that reason, the percentages should be read as registry-listed figures, not as a basis for reconstructing participant counts or comparing rates between groups.
As a general statistical point, small group sizes make rare or serious events difficult to characterize precisely. Counts describe what was observed in the study; they do not on their own determine whether an event was caused by treatment or predict how often it would occur in a broader population. The registry record does not report an inferential comparison of serious adverse events.
13. What the Result Does, and Does Not, Mean
The posted results show that the registry recorded any treatment-emergent adverse event for 85.7% of the placebo group and 93.3% of the BI 1291583 5 mg group in the Treated Set. The serious adverse-event figures are 1 affected participant in the placebo group and 5 in the BI 1291583 group, with 0 deaths reported in both groups. These are observations from the trial as recorded, not definitive estimates of what would happen in other settings.
The findings do not establish that BI 1291583 caused any particular event, nor do they show that the groups differ statistically. The registry record does not report a confidence interval or formal statistical comparison for the primary outcome. The broad any-event endpoint also does not convey event severity, duration, recurrence, or attribution. Serious-event terms provide additional descriptive context, but their listed percentages lack accompanying denominators in the record.
The trial’s phase, population, and duration also define the scope of interpretation. It was a phase 2 study in adults with cystic fibrosis bronchiectasis, with daily dosing for 12 weeks and follow-up described as extending through the last dose plus a residual effect period, up to 16 weeks, for the primary endpoint. These results should not be treated as a complete account of long-term safety or as a direct estimate for populations outside the study’s stated eligibility.
As a general statistical principle, observed percentages are estimates subject to sampling variability. In this study, the treated-set group sizes were 7 and 15, so the point estimates warrant particular caution. The record does not provide the inferential quantities needed to assess the uncertainty of the between-group contrast. The results therefore support a description of what was recorded in the trial, but not a firm conclusion about comparative risk or treatment effect.
14. Why This Trial Matters Statistically
This trial is statistically informative because it illustrates the difference between reporting observed percentages and estimating a comparative effect with precision. The primary endpoint is a familiar binary safety measure, but the group sizes are small: the Treated Set includes 7 placebo participants and 15 participants assigned to BI 1291583 5 mg. In groups of this size, the outcome of an individual participant can materially affect a percentage. Reading the percentages without that context can make them seem more definitive than the underlying information supports.
The endpoint also demonstrates why outcome definitions matter. “Any treatment-emergent adverse event” summarizes whether participants experienced an event during a specified period. It is not a measure of the number of events, their severity, or their duration. The separately reported serious adverse-event counts address a narrower category. Together, these summaries provide different descriptive views, but neither substitutes for an estimate of uncertainty or a causal comparison.
The record’s lack of a reported inferential analysis is consequential. Without a confidence interval or formal comparison, readers cannot assess the precision of the apparent separation between the primary percentages. The registry also lists 5 secondary outcomes, while the multiplicity strategy is not reported. This makes it important to distinguish exploratory outcome reporting from evidence that would support a confirmatory claim.
Finally, sample-size planning and observed results answer different questions. A planning illustration can show how assumptions relate to a future study’s size, but it is not evidence of observed power or a result of this trial. For this binary endpoint, the registry indicates that planning values are missing or not estimable for a two-arm comparison. The central statistical lesson is to keep descriptive safety findings, uncertainty, study planning, and causal interpretation separate.
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 posted primary results are descriptive percentages without a reported confidence interval, p-value, or formal between-group analysis. The registry lists 0 analyses. As a result, the precision of the primary comparison and its statistical compatibility with different effect sizes cannot be assessed from the record.
The Treated Set is defined by having taken at least one dose, but participant flow into that population is not described in detail. The registry record does not report how many randomized participants, if any, were excluded from this set or why. It also does not report missing outcome counts, the method used to handle missing data, or sensitivity analyses. These omissions limit evaluation of attrition and analysis-population choices.
The study was small, with treated-set group sizes of 7 for placebo and 15 for BI 1291583 5 mg. Such group sizes limit the precision available for event percentages and make rare outcomes difficult to characterize. The serious-event term percentages are listed without denominators alongside each term, and the record does not specify the group attribution for every term. Causal relationships between reported events and study treatment are not established by those listings.
The registry record does not report a statistical analysis plan, a multiplicity approach for the 5 secondary outcomes, the trial’s sample-size justification, or details of interim analyses. It also does not provide inferential results for the listed secondary outcomes. These are limitations of what can be interpreted from the registry record; they should not be treated as evidence that a particular method was or was not used outside the record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™) — NCT05865886.
- Registry record last updated 2026-06-23; status last verified 2026-05.
- Results first posted 2025-11-18.
- 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.
Continue through the Clinical Biostats statistical pathway
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19. Record Summary
NCT05865886, Clairafly™, is a completed phase 2 randomized, quadruple-masked, parallel-group trial sponsored by Boehringer Ingelheim. It studied BI 1291583 5 mg versus placebo in adults with cystic fibrosis bronchiectasis. The study description specifies one tablet once daily for 12 weeks. The registry lists enrollment of 22, a start date of 2024-04-05, and a primary completion date of 2024-10-07.
The primary endpoint was the percentage of the Treated Set experiencing any treatment-emergent adverse event during the defined observation period. The posted values are 85.7% for placebo and 93.3% for BI 1291583 5 mg. Serious adverse events affected 1 placebo participant and 5 BI 1291583 participants; 0 deaths were reported in either group. The record lists 5 secondary outcomes and 0 analyses. It does not report a formal inferential comparison or confidence interval for the primary outcome, limiting assessment of the precision of the observed percentages.