Trial · NCT05870956
Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
NCT05870956, Completed, Boehringer Ingelheim; results first posted 2024-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients. Trials, record NCT05870956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05870956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
- NCT number
- NCT05870956
- Status
- Completed
- Enrollment
- 1,798 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Nintedanib
- First posted
- 2023-05-23
- Last updated
- 2024-10-01
- Results first posted
- 2024-10-01
- Limitations and caveats
The study limitations included: the data source was composed of administrative claims; the adherence exposure was based on prescription fill data; the outcomes were measured contemporaneously with nintedanib adherence; the outcomes consisted of inpatient hospitalization and total medical spending; the early-poor adherence group consisted of a smaller sample; sample selection bias due to the time frame chosen for patient selection; COVID-19 might have impacted health care consumption patterns.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total All-cause Medical Costs | At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Total all-cause medical costs per patient calculated as the sum of the total amounts paid for all medical services by the payer and the patient. The types of medical services covered by Medicare included inpatient facility, outpatient facility, skilled nursing facility, home health care, hospice, durable medical equipment, clinician office visits, and other physician services covered under the Part B benefit. The costs with prescriptions covered under Part D benefit were excluded from this outcome analysis. |
| Secondary | Total IPF-related Medical Costs | At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | The total Idiopathic Pulmonary Fibrosis (IPF) related medical costs per patient were calculated as the sum of the total amounts paid by the payers and the patients for all medical services for an IPF-related reason containing at least one IPF diagnosis code. |
| Secondary | All-cause Inpatient Hospitalization | At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Percentage of patients with at least one inpatient hospitalization for any cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place. |
| Secondary | IPF-related Inpatient Hospitalization | At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Percentage of patients with at least one inpatient hospitalization for any Idiopathic Pulmonary Fibrosis (IPF)-related cause in the first year of nintedanib initiation. Percentages were rounded to one decimal place. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total All-cause Medical Costs | At day 360 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria. | United States dollars | MEAN |
| SECONDARY | Total IPF-related Medical Costs | At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria. | United States dollars | MEAN |
| SECONDARY | All-cause Inpatient Hospitalization | At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria. | Percentage of participants | NUMBER |
| SECONDARY | IPF-related Inpatient Hospitalization | At year 1 after the index date, i.e., between 01-Oct-2014 and 31-Oct-2018. | Full analysis set: Community-dwelling Idiopathic Pulmonary Fibrosis (IPF) patients with Medicare hospital, physician and pharmacy coverage data, between 01-Oct-2013 to 31-12-2020, who met all inclusion criteria and none of the exclusion criteria. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total All-cause Medical Costs | High Nintedanib Adherence | 12647.73 | Standard Deviation 16996 | United States dollars | |
| Total All-cause Medical Costs | Moderate Nintedanib Adherence | 13580.61 | Standard Deviation 18479 | United States dollars | |
| Total All-cause Medical Costs | High-then-poor Nintedanib Adherence | 17549.74 | Standard Deviation 27854 | United States dollars | |
| Total All-cause Medical Costs | Delayed-poor Nintedanib Adherence | 15375.10 | Standard Deviation 16999 | United States dollars | |
| Total All-cause Medical Costs | Early-poor Nintedanib Adherence | 18110.14 | Standard Deviation 26365 | United States dollars | |
| Total IPF-related Medical Costs | High Nintedanib Adherence | 3239.75 | Standard Deviation 6313 | United States dollars | |
| Total IPF-related Medical Costs | Moderate Nintedanib Adherence | 2935.82 | Standard Deviation 4574 | United States dollars | |
| Total IPF-related Medical Costs | High-then-poor Nintedanib Adherence | 6011.81 | Standard Deviation 16239 | United States dollars | |
| Total IPF-related Medical Costs | Delayed-poor Nintedanib Adherence | 3696.54 | Standard Deviation 6525 | United States dollars | |
| Total IPF-related Medical Costs | Early-poor Nintedanib Adherence | 3860.62 | Standard Deviation 12947 | United States dollars |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Nintedanib Adherence | 781 | |
| Overall Study | STARTED | Moderate Nintedanib Adherence | 202 | |
| Overall Study | STARTED | High-then-poor Nintedanib Adherence | 190 | |
| Overall Study | STARTED | Delayed-poor Nintedanib Adherence | 255 | |
| Overall Study | STARTED | Early-poor Nintedanib Adherence | 370 | |
| Overall Study | COMPLETED | High Nintedanib Adherence | 781 | |
| Overall Study | COMPLETED | Moderate Nintedanib Adherence | 202 | |
| Overall Study | COMPLETED | High-then-poor Nintedanib Adherence | 190 | |
| Overall Study | COMPLETED | Delayed-poor Nintedanib Adherence | 255 | |
| Overall Study | COMPLETED | Early-poor Nintedanib Adherence | 370 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Nintedanib Adherence | 0 | 0 |
| Total, all-cause mortality | Moderate Nintedanib Adherence | 0 | 0 |
| Total, all-cause mortality | High-then-poor Nintedanib Adherence | 0 | 0 |
| Total, all-cause mortality | Delayed-poor Nintedanib Adherence | 0 | 0 |
| Total, all-cause mortality | Early-poor Nintedanib Adherence | 0 | 0 |
| Total, other adverse events | High Nintedanib Adherence | 0 | 0 |
| Total, other adverse events | Moderate Nintedanib Adherence | 0 | 0 |
| Total, other adverse events | High-then-poor Nintedanib Adherence | 0 | 0 |
| Total, other adverse events | Delayed-poor Nintedanib Adherence | 0 | 0 |
| Total, other adverse events | Early-poor Nintedanib Adherence | 0 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05870956
GET https://conductscience.org/api/trials/v1/NCT05870956/registered