Dose Reduction and Discontinuation With Anti-Fibrotic Medications
Completed
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.
Key facts
- Study ID
- NCT05779007
- Run by
- Boehringer Ingelheim
- People needed
- 2778
- Starts
- 2023-04-18
- Expected to finish
- 2023-07-14
- Last updated by the study team
- 2025-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date)
- Evidence of IPF: patient with at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF during the study period (10/01/2013 to 09/30/2022)
- At least 18 years old at the index date
- Have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period
You may not qualify if…
- Any history of lung transplant during the 12-months pre-index/baseline period
- Any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period
- Evidence of non-IPF chronic fibrosis Interstitial Lung Disease (ILD) or connective tissue diseases during the 12-months pre-index period. The following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's syndrome, and mixed connective tissue disease (CTD), sarcoidosis, and hypersensitivity pneumonitis).
- Missing demographic information (i.e., age or sex)
Where it is running
- Boehringer Ingelheim — Ridgefield, Connecticut, United States
Full record on ClinicalTrials.gov
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