Dose Reduction and Discontinuation With Anti-Fibrotic Medications

NCT05779007 | Completed Results FDA Drug

• 1 other identifier: 1199-0526
• Study Type: observational
• Target: 2,778
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months

  Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib. Number of patients with sub-optimal dosing by month 12 is reported.

  From individual index date up to 12 months.

Secondary Outcomes (1)

• Time to Treatment Discontinuation

  From individual index date up to 12 months.

Study Arms (2)

Pirfenidone initiators cohort

IPF patients from the Optum Research Database (ORD) who presented at least one pirfenidone prescription during the identification period (the date of first prescription for pirfenidone was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.

Drug: Pirfenidone

Nintedanib initiators cohort

IPF patients from the Optum Research Database (ORD) who presented at least one nintedanib prescription during the identification period (the date of first prescription for nintedanib was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.

Drug: Nintedanib

Interventions

Pirfenidone DRUG

Pirfenidone

Pirfenidone initiators cohort

Nintedanib DRUG

Nintedanib

Nintedanib initiators cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with idiopathic pulmonary fibrosis (IPF) who initiated either pirfenidone or nintedanib between October 2014 and September 2021.

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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim

Ridgefield, Connecticut, 06877, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone; nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Healthcare claims data not designed for research, may not represent actual medication use. Reasons for discontinuations/dose reduction could not be ascertained as are not captured in claims database (CDB). Adverse events could not be evaluated as these are not reliably captured in CDB. Due to lack of availability of laboratory data/clinical information, severity of IPF+results of laboratory tests were not observed. ORD only covers patients with commercial insurance or Medicare Advantage plan.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: April 18, 2023
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)