Dose Reduction and Discontinuation With Anti-Fibrotic Medications (NCT05779007) | Clinical Trial Compass
CompletedNot Applicable
Dose Reduction and Discontinuation With Anti-Fibrotic Medications
United States2,778 participantsStarted 2023-04-18
Plain-language summary
The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months
Timeframe: From individual index date up to 12 months.