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 Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) (NCT04097223), a registered phase not stated study. The primary outcome is Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04097223 |
| Phase | Phase not stated |
| Condition | Pulmonary Disease, Chronic Obstructive |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 17464 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with newly diagnosed, incident chronic obstructive pulmonary disease (COPD) in German claims data. The COPD-12 sample included patients in the database between April 2015 and March 2018 who had 12 months of follow-up from the index date, defined as the date of the first COPD diagnosis. The primary outcome description focuses on patients in that sample who received any long-term COPD treatment. The record reports a COPD-12 patient population of N=8238 in its note about fourth-line therapy.
Intervention
This is not a trial of an assigned intervention. It describes real-life drug treatment after diagnosis, including treatment by therapy line and treatment changes during follow-up. The record names LABA (long-acting beta agonist), LAMA (long-acting muscarinic antagonist), and ICS (inhaled corticosteroids) as treatment terminology. It does not provide an intervention assignment or a protocol-defined treatment strategy for comparison.
Comparator
No randomized comparator is identified. The registry record does not state an allocation method, and the listed treatment arms are not mutually exclusive: patients could switch to another treatment during follow-up. Consequently, the treatment descriptions do not constitute like-for-like control groups. Differences between treatment groups, if calculated elsewhere, would need to be interpreted with this observational structure in mind.
Primary question
The primary outcome is a description of the percentage of patients receiving real-life drug treatment after incident COPD diagnosis, reported by treatment and therapy line during the first 12 months after the index date. The clinical question is descriptive: what treatment was recorded after diagnosis? The registry record does not report the percentages, their uncertainty, or a treatment-effect comparison. It therefore does not establish whether one treatment strategy is better than another.
3. Trial Design
This completed study is a retrospective analysis of German health-insurance claims data, with the official title “Real-world Treatment of Newly Diagnosed COPD Patients: A Retrospective German Claims Data Analysis.” Boehringer Ingelheim is listed as the sponsor. The registry reports enrollment of 17464. The study start date is 2019-11-20, and the primary completion date is 2020-07-01.
The record describes a COPD-12 sample of patients included in a German claims database between April 2015 and March 2018, with follow-up for 12 months from the index date. The index date is the first COPD diagnosis. The brief summary says the analysis uses an exact follow-up period of 12 months, with subgroup analyses at 24 and 36 months. It also says patients are censored only if they die during the respective follow-up period. Further operational details of that censoring rule are not reported in the registry record.
The primary outcome concerns the percentage of patients by treatment and therapy line. Its population description refers to patients who received any long-term COPD treatment. Treatment categories are not mutually exclusive because patients could switch treatment during follow-up. The registry notes that fewer than 5% of the patient population (N=8238) received COPD-12 fourth-line therapy.
This is not described as a randomized comparison. Allocation is not stated, and the listed treatment groups are not identified as equivalent control arms. The registry lists 19 outcome measures, including outcomes concerning guideline-concordant treatment, exacerbations, outpatient visits, hospitalizations, time to first all-cause hospitalization, and direct treatment costs. The record reports no statistical analyses. Details such as the claims database name, eligibility rules beyond those described, confounder adjustment, and the statistical analysis plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Only subjects that met all inclusion and none of the exclusion criteria were included in the study.
Overall Study
| Stage | COPD-FULL Sample |
|---|---|
| STARTED | 17464 |
| COMPLETED | 17464 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All patients included in the COPD-12 sample, who received any long term-COPD treatment. Patients are reported by therapy line (arms are not mutually exclusive). The number of patients who received COPD-12 Fourth Line Therapy is less than 5% of the patient population (N=8238). As defined in the protocol, data collected only for treatment pattern combinations that were observed in \>5% in patient population.
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: Patients with newly diagnosed chronic obstructive pulmonary disease (Incident COPD patients).
| Characteristic | Unit | COPD-FULL Sample |
|---|---|---|
| Participants analysed | 17464 | |
| Age, Continuous | Years | 71.5 (SD 12.3) |
| Sex/Gender, Customized: Female | Percentage of participants | 41.4 |
| Sex/Gender, Customized: Male | Percentage of participants | 58.6 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample, measured over Up to 12 months after the index date..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Patients |
| Endpoint classification | Binary Endpoint |
The primary outcome measures the percentage of patients in the COPD-12 sample who received real-life COPD drug treatment after an incident diagnosis, described by treatment and therapy line. The stated timeframe is up to 12 months after the index date. The index date is the date of the incident, or first, COPD diagnosis. The outcome description defines LABA as long-acting beta agonist, LAMA as long-acting muscarinic antagonist, and ICS as inhaled corticosteroids.
A percentage is a descriptive measure: it expresses how common a recorded treatment category is within a stated population. It can help characterize treatment patterns in the claims data, but its interpretation depends on the population used as the denominator and on how treatment categories are defined. The outcome description focuses on patients who received any long-term COPD treatment. It also notes that treatment arms are not mutually exclusive because patients could switch to another treatment during follow-up. A patient may therefore contribute to more than one treatment description; these categories should not be read as separate, fixed groups.
The registry record does not report the primary outcome percentages, denominators by treatment, confidence intervals, or a comparison of treatments. It also does not report the detailed definitions used to assign each therapy line. The endpoint is therefore described in the record, but its numerical findings and precision are not available there.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a descriptive primary outcome, but it does not report numerical results for that outcome. There are no posted percentages by treatment or therapy line in the record, and no confidence intervals or other measures of uncertainty are reported. The outcome description alone cannot establish how common any treatment was in the analyzed population.
The record lists enrollment of 17464, while the primary outcome population description refers to a COPD-12 population of N=8238 in its statement about fourth-line therapy. Those figures describe different record fields and should not be combined or treated as interchangeable denominators. The record does not provide the treatment-specific denominators needed to interpret percentages, nor does it describe how the enrollment figure relates to each analysis population.
The study is a retrospective claims-data analysis rather than a randomized treatment comparison. The registry does not state an allocation method, and treatment arms are explicitly not mutually exclusive because patients could switch treatments. Thus, a treatment category is not necessarily a group that remained on one treatment throughout follow-up. Even if treatment-specific percentages were available, they would describe recorded use and would not, by themselves, show that treatment caused an outcome or that groups were comparable.
The primary follow-up period is 12 months from first diagnosis. The study summary also mentions subgroup analyses at 24 and 36 months and says censoring occurs only when a patient dies during the respective follow-up period. The registry does not provide the underlying outcome results or enough detail to assess how death, incomplete claims observation, or other data limitations affected each outcome.
The record lists 19 outcome measures but reports zero statistical analyses. It does not provide hypothesis tests, adjusted estimates, confidence intervals, or an account of which outcome analyses were completed. The appropriate reading is therefore limited to the study’s stated aims, populations, and outcome definitions. Numerical conclusions about treatment patterns or associations are not reported in the registry record.
9. Statistical Methods Explained
The registry describes a retrospective claims-data analysis. In general, claims data record health-care encounters and billed treatments; they can be used to describe patterns of care in an identified population. They do not necessarily contain all clinical details relevant to treatment decisions or disease severity. The registry record does not describe the claims database name, the validation of its COPD or treatment definitions, or the handling of all sources of missing information.
What does a treatment percentage describe?
In general, a percentage is the number of people meeting a definition divided by the relevant population, expressed as a share. Its meaning depends on a clear numerator and denominator. For this primary outcome, the stated measure is the percentage of patients per treatment and therapy line among patients receiving any long-term COPD treatment in the COPD-12 sample. The record does not report the actual numerators or denominators by treatment, so the percentages cannot be independently interpreted from the registry information.
The treatment categories are not mutually exclusive because patients could switch treatments during follow-up. In general, when categories overlap, their percentages should not be assumed to sum to a whole or to represent separate groups. A percentage for a treatment category describes membership in that category as defined by the analysis, not necessarily continuous use of that treatment. The registry record does not report the detailed coding rules or whether treatment was defined by initiation, any use, or another claims-based criterion.
What does the follow-up description imply?
The primary timeframe is up to 12 months after the index date, which is the first COPD diagnosis. The brief summary describes an exact 12-month follow-up period, and subgroup analyses with 24- and 36-month follow-up. It states that censoring is done only if a patient dies during the respective period. In general, censoring means that follow-up stops for an individual before the outcome can be observed for the entire period. The handling of censoring can affect which observations contribute to an analysis. The registry does not report further details about follow-up completeness, other reasons observation might end, or how the described censoring was implemented for each outcome.
How should uncertainty and testing be read?
In general, a confidence interval describes a range of estimates compatible with the data under the assumptions of the method. It helps show how precisely an estimate is measured; it does not guarantee that the true value lies in the interval or address bias in the data. No confidence intervals for the primary endpoint are reported in the registry record. The record also reports no statistical analyses, so it does not identify a model, adjustment set, hypothesis test, or estimate of association for this endpoint.
For binary outcomes, uncertainty can depend on the number of observations and on how the data were sampled and analyzed. General methods may need to account for clustering, repeated observations, or other departures from simple independent observations. Over-dispersion, in general, occurs when variability exceeds what a chosen statistical model expects; ignoring it can make uncertainty appear too small. The registry record does not say that over-dispersion was assessed, nor does it describe repeated-measure or cluster-adjusted methods. These are general considerations, not claims about analyses conducted in this study.
What do the planning calculations represent?
The planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They frame the effect to detect as a stated fraction of the observed effect. For time-to-event calculations, the stated method uses the total number of events with a Schoenfeld approach; other calculations express participants per arm. These are planning illustrations based on an observed effect, not observed power and not evidence that the original study was designed with those assumptions. The registry record does not report the numerical observed effect or the numerical planning estimates in the information describing this trial, and it does not report that these were the study’s own design assumptions.
In general, a planning sample size describes the number of participants or events that a hypothetical design would require under selected assumptions. It is not a result from the completed analysis, and it cannot substitute for an effect estimate with uncertainty. Because the study is observational and the registry does not report a like-for-like treatment comparison, the equal-allocation assumption in a planning illustration should not be mistaken for the study’s actual allocation. Allocation is not stated in the registry record.
What can the listed outcomes add?
The secondary outcomes concern guideline alignment, exacerbations, outpatient visits, hospitalizations, time to first all-cause hospitalization, and direct treatment costs. In general, binary percentages, event counts, rates, and time-to-event measures answer different questions and require outcome-specific definitions and methods. For example, a time-to-event outcome concerns the timing of an event as well as whether it occurs. The registry lists these outcome topics but does not report their numerical results, analysis methods, or uncertainty estimates. No particular model should be inferred from an outcome title alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 19 outcome measures, including the primary treatment description and secondary outcomes involving guideline alignment, exacerbations, visits, hospitalizations, time to first all-cause hospitalization, and costs. When a study examines multiple outcomes or multiple treatment categories, general statistical practice recognizes that the chance of at least one apparently unusual result can increase if many tests are conducted. Methods such as prespecifying a primary analysis or adjusting for multiple comparisons can address different aspects of that issue. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or a statistical analysis plan. Since it reports zero statistical analyses, there are no test results in the record to interpret in light of multiplicity.
The record describes a 12-month primary follow-up and subgroup analyses at 24 and 36 months. It states that patients are censored only if they die during the respective follow-up period. Beyond that statement, handling of missing observations, incomplete claims coverage, and other possible gaps in follow-up is not reported in the registry record. The record does not say whether missingness was assessed, whether any imputation was used, or whether sensitivity analyses were conducted.
The primary outcome population is described as patients in the COPD-12 sample who received any long-term COPD treatment. The registry also mentions a COPD-12 patient population of N=8238 in connection with fourth-line therapy. It does not provide full inclusion and exclusion rules or treatment-specific analysis denominators. The analysis populations for each secondary outcome are not fully described in the information available. No adjustment for confounding or other covariates is reported. These omissions limit assessment of how representative each analysis population is and how robust any potential result would be.
11. What the Result Does, and Does Not, Mean
The study’s stated purpose is to describe real-life COPD drug treatment after an incident diagnosis using German claims data. Its primary outcome is a percentage by treatment and therapy line over the first 12 months after the index date. The registry also describes other outcome topics, including exacerbations, outpatient visits, hospitalizations, time to first all-cause hospitalization, and treatment costs. These aims indicate the kinds of patterns the study was intended to characterize.
The registry record does not report numerical results for the primary outcome or the listed secondary outcomes. It therefore does not establish the observed percentage receiving any treatment, how treatment patterns varied across therapy lines, or how often the secondary outcomes occurred. Nor does it report estimates of precision, such as confidence intervals. A treatment description without the relevant numbers cannot show the magnitude or reliability of a pattern.
Even with numerical findings, a retrospective claims analysis would describe associations and recorded care rather than establish that a treatment caused a particular outcome. Treatment arms are not mutually exclusive because patients could switch during follow-up, and the record does not identify a randomized comparator. Treatment groups should therefore not be treated as equivalent groups assigned to different strategies. The registry record does not report adjustment for differences among patients or other methods that might address confounding.
The enrollment figure of 17464 and the COPD-12 population reference of N=8238 pertain to different descriptions in the record; the record does not provide the analysis-specific denominators needed to reconcile them. A fourth-line therapy note says that fewer than 5% of the stated patient population received it, but the registry does not provide the underlying treatment counts or uncertainty for that statement.
In short, the record supports a description of the study design and intended measures, not a numerical account of the findings. It cannot establish comparative effectiveness, causation, or the absence of an outcome. Those conclusions require reported results and methods that are not present in the registry record.
12. Why This Trial Matters Statistically
Claims-based studies can provide a way to describe treatment patterns in routine care, rather than only under a treatment assignment specified by a randomized trial. This analysis focuses on patients after a first COPD diagnosis and on treatment recorded during follow-up. Such a descriptive question can be useful for understanding how care is characterized in administrative data and for identifying areas that may warrant further investigation. The registry record, however, does not report the numerical treatment patterns needed to draw those descriptive conclusions.
The statistical structure matters because treatment categories overlap. Patients could switch to another treatment during follow-up, so the listed arms are not mutually exclusive. This is materially different from a study in which each participant is assigned to one treatment group and remains classified there. Percentages across overlapping categories cannot be interpreted as a partition of the cohort, and a direct contrast between categories would not automatically be a causal comparison.
The registry also specifies different follow-up windows: 12 months for the primary sample and subgroup analyses at 24 and 36 months. Longer observation can address outcomes over a different period, but in general it can also change which patients remain observable and how outcomes are defined. The record gives a censoring statement but does not provide the detailed methods needed to assess these issues for each outcome.
Statistically, the distinction between a planned question and a reported result is essential. The registry lists 19 outcomes, but reports no statistical analyses and no numerical primary outcome findings. The study can therefore be discussed as a real-world descriptive design, while claims about treatment frequencies, differences, precision, or causal effects remain unsupported by the registry record.
13. 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 most immediate limitation for interpreting the findings is that the registry record does not report numerical results for the primary endpoint or secondary outcomes. It lists 19 outcome measures but reports zero statistical analyses. Without outcome estimates, denominators by treatment, or uncertainty measures, the treatment patterns and their precision cannot be assessed from the record.
The design is retrospective and uses claims data. The registry record does not name the database or describe validation of diagnostic and treatment coding, completeness of claims capture, or the availability of clinical characteristics. It does not report how potential confounding was handled. These details matter when assessing whether recorded treatment patterns reflect underlying clinical differences or data-capture processes.
The treatment categories are explicitly not mutually exclusive because patients could switch treatments. The record does not provide the detailed rules defining treatment exposure or therapy lines. This makes it difficult to determine how an individual was classified over the follow-up period or how to interpret a percentage for a particular category. The treatment population is described as receiving any long-term COPD treatment, but complete eligibility criteria and analysis-specific denominators are not reported.
Follow-up is described as 12 months, with subgroup analyses at 24 and 36 months, and death is stated to be the only reason for censoring. The record does not explain how incomplete claims observation or other possible data gaps were handled. It also does not report whether missing-data assessments, sensitivity analyses, or competing-risk methods were used.
The record notes that fewer than 5% of the COPD-12 patient population (N=8238) received fourth-line therapy, but it does not report the underlying count or uncertainty. It lists 5238 deaths for the COPD-FULL Sample in the adverse-event fields, alongside zero values for serious and other affected-event counts and no top serious terms. The record does not give sufficient context or denominators to interpret these entries as evidence about event risk or safety.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) — NCT04097223.
- Registry record last updated 2022-02-24; status last verified 2022-02.
- Results first posted 2021-09-09.
- 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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17. Record Summary
NCT04097223 is a completed retrospective German claims-data analysis sponsored by Boehringer Ingelheim. It concerns real-life treatment after newly diagnosed COPD. The registry reports enrollment of 17464, a study start date of 2019-11-20, and a primary completion date of 2020-07-01.
The primary outcome describes the percentage of patients by COPD treatment and therapy line during the first 12 months after the first diagnosis. The COPD-12 sample is described as patients in German claims data between April 2015 and March 2018 with 12 months of follow-up. Subgroup analyses at 24 and 36 months are also mentioned. Treatment categories are not mutually exclusive because patients could switch treatments.
The record lists 19 outcome measures but reports no statistical analyses or numerical primary outcome results. It does not report the detailed statistical plan, outcome estimates, or their precision. The study is therefore described by its design and intended outcomes, while its numerical findings are not reported in the registry record.