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N/A Completed N=8,370

Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Source: ClinicalTrials.gov NCT05779007 ↗
Enrolled (actual)
8,370
Serious AEs
Results posted
Jul 2025
Primary outcomePrimary: Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months — 301; 373 Participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
301; 373
SECONDARY
Time to Treatment Discontinuation
257.47; 246.56

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05779007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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