Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Nintedanib; Drug: Pirfenidone

• Registration Number: NCT05779007
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Study Start: 2023-04-18
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2778

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nintedanib initiators	Nintedanib	Patients who initiated nintedanib treatment
Pirfenidone initiators	Pirfenidone	Patients who initiated pirfenidone treatment

Primary Outcome Measures

Name	Time	Method
Incidence of dose reduction and/or temporary dose reduction	up to 12 months	Incidence of dose reduction/interruption will be defined as average daily dose not following the prescribing information of nintedanib and pirfenidone, for at least 60 consecutive days. Correspondence to ≤ 90% dose strength for pirfenidone or ≤ 66.67% dose strength for nintedanib

Secondary Outcome Measures

Name	Time	Method
Drug discontinuation	up to 12 months	Defined as: Presence of sixty or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)

Trial Locations

Locations (1)

Boehringer Ingelheim; 🇺🇸 Ridgefield, Connecticut, United States