Trial · NCT05779007
Dose Reduction and Discontinuation With Anti-Fibrotic Medications
NCT05779007, Completed, Boehringer Ingelheim; results first posted 2025-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Reduction and Discontinuation With Anti-Fibrotic Medications. Trials, record NCT05779007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05779007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Reduction and Discontinuation With Anti-Fibrotic Medications
- NCT number
- NCT05779007
- Status
- Completed
- Enrollment
- 2,778 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Pirfenidone, Nintedanib
- First posted
- 2023-03-22
- Last updated
- 2025-07-28
- Results first posted
- 2025-07-28
- Limitations and caveats
Healthcare claims data not designed for research, may not represent actual medication use.~Reasons for discontinuations/dose reduction could not be ascertained as are not captured in claims database (CDB).~Adverse events could not be evaluated as these are not reliably captured in CDB.~Due to lack of availability of laboratory data/clinical information, severity of IPF+results of laboratory tests were not observed.~ORD only covers patients with commercial insurance or Medicare Advantage plan.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | From individual index date up to 12 months. | Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib. Number of patients with sub-optimal dosing by month 12 is reported. |
| Secondary | Time to Treatment Discontinuation | From individual index date up to 12 months. | Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | From individual index date up to 12 months. | Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Discontinuation | From individual index date up to 12 months. | Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021. Only IPF patients with event were included in the analysis. | Days | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | Nintedanib Initiators Cohort | 301 | Participants | ||
| Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | Pirfenidone Initiators Cohort | 373 | Participants | ||
| Time to Treatment Discontinuation | Nintedanib Initiators Cohort | 257.47 | Standard Deviation 130.29 | Days | |
| Time to Treatment Discontinuation | Pirfenidone Initiators Cohort | 246.56 | Standard Deviation 134.55 | Days |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib Initiators Cohort | 4,972 | |
| Overall Study | STARTED | Pirfenidone Initiators Cohort | 3,398 | |
| Overall Study | Propensity Score Matched Patients | Nintedanib Initiators Cohort | 1,389 | |
| Overall Study | Propensity Score Matched Patients | Pirfenidone Initiators Cohort | 1,389 | |
| Overall Study | COMPLETED | Nintedanib Initiators Cohort | 1,455 | |
| Overall Study | COMPLETED | Pirfenidone Initiators Cohort | 1,389 | |
| Overall Study | NOT COMPLETED | Nintedanib Initiators Cohort | 3,517 | |
| Overall Study | NOT COMPLETED | Pirfenidone Initiators Cohort | 2,009 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib Initiators Cohort | 0 | 0 |
| Total, all-cause mortality | Pirfenidone Initiators Cohort | 0 | 0 |
| Total, other adverse events | Nintedanib Initiators Cohort | 0 | 0 |
| Total, other adverse events | Pirfenidone Initiators Cohort | 0 | 0 |
| Total, serious adverse events | Nintedanib Initiators Cohort | 0 | 0 |
| Total, serious adverse events | Pirfenidone Initiators Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nintedanib Initiators Cohort vs Pirfenidone Initiators Cohort: Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months |
Source Trial comparisons
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/NCT05779007
GET https://conductscience.org/api/trials/v1/NCT05779007/registered