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Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Completed

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Nintedanib
Drug: Pirfenidone

Study type

Observational

Funder types

Industry

Identifiers

NCT05779007
1199-0526

Details and patient eligibility

About

The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.

Enrollment

2,778 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Trial design

2,778 participants in 2 patient groups

Pirfenidone initiators
Description:
Patients who initiated pirfenidone treatment
Treatment:
Drug: Pirfenidone
Nintedanib initiators
Description:
Patients who initiated nintedanib treatment
Treatment:
Drug: Nintedanib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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