An observational study in Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Boehringer Ingelheim · Observational
The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's enrollment of 2,778 is above the median of 158 across 154 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with idiopathic pulmonary fibrosis (IPF) who initiated either pirfenidone or nintedanib between October 2014 and September 2021.
Exclusion Criteria:
IPF patients from the Optum Research Database (ORD) who presented at least one pirfenidone prescription during the identification period (the date of first prescription for pirfenidone was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.
Drug: Pirfenidone
IPF patients from the Optum Research Database (ORD) who presented at least one nintedanib prescription during the identification period (the date of first prescription for nintedanib was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.
Drug: Nintedanib
Pirfenidone
Nintedanib
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 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.
Time frame: From individual index date up to 12 months.
Time to Treatment Discontinuation
Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)
Time frame: From individual index date up to 12 months.
This was a retrospective cohort study to assess the dose reduction/interruption and discontinuation with nintedanib and pirfenidone initiators among patients with Idiopathic Pulmonary Fibrosis (IPF) from the Optum Research Database (ORD) who initiated either pirfenidone or nintedanib between October 2014 and December 2021.
| Milestone | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort |
|---|---|---|
| Started | 4972 | 3398 |
| Propensity score matched patients | 1389 | 1389 |
| Completed | 1455 | 1389 |
| Not completed | 3517 | 2009 |
| Withdrew: Not meeting eligibility criteria | 3517 | 2009 |
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.
| Participants | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort |
|---|---|---|
| Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months | 301 | 373 |
Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)
| Days | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort |
|---|---|---|
| Time to Treatment Discontinuation | 257.47 ± 130.29 | 246.56 ± 134.55 |
Collected over Adverse event information was not applicable for this study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nintedanib Initiators Cohort | — | — | — |
| Pirfenidone Initiators Cohort | — | — | — |
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.
| Age, Continuous(years) | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort | Total |
|---|---|---|---|
| Mean | 73.4 ± 7.6 | 73.9 ± 7.6 | 73.52 ± 7.54 |
| Sex: Female, Male(Participants) | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort | Total |
|---|---|---|---|
| Female | 534 | 549 | 1083 |
| Male | 855 | 840 | 1695 |
| Race and Ethnicity Not Collected(Participants) | Nintedanib Initiators Cohort | Pirfenidone Initiators Cohort | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Idiopathic Pulmonary Fibrosis→
Boehringer Ingelheim