Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Assessment of the Dose Reduction and Discontinuation Associated With Anti-Fibrotic Medications in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05779007
• Other study ID #: 1199-0526
• Status: Completed
• Start date: April 18, 2023
• Est. completion date: July 14, 2023

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2778
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Pirfenidone
Pirfenidone
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
United States	Boehringer Ingelheim	Ridgefield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose reduction and/or temporary dose reduction	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	up to 12 months
Secondary	Drug discontinuation	Defined as: Presence of sixty or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)	up to 12 months

External Links

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