A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

Boehringer Ingelheim

Status

Completed

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Pirfenidone

Other: Untreated Cohort

Drug: Nintedanib

Study type

Observational

Funder types

Industry

Identifiers

NCT03958071

1199-0375

Details and patient eligibility

About

To understand differences in characteristics of Idiopathic Pulmonary Fibrosis (IPF) patients who are prescribed nintedanib compared to those who are prescribed pirfenidone.

Enrollment

13,264 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

With ≥ 1 diagnosis for IPF (the International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 516.3, 516.31, 515, or ICD-10-CM codes J84.112) in the EMR between October 1, 2013 to April 30, 2018
With ≥ 1 prescription for nintedanib between October 1, 2014 and April 30, 2018 (the selection window)
The date of the first prescription will be defined as the index date
With ≥ 1 record in the EMR database during the 12 months prior to the index date (the pre-index period)
With ≥ 1 diagnosis of IPF during the 12 months prior to the index date
Age ≥ 40 on the index date
IQVIA will explore also requiring ≥ 1 chest CT scan before first IPF diagnosis during the pre-index period

Exclusion criteria

With ≥ 1 diagnosis of other known causes of interstitial lung disease (ILD) on the date of or after the first IPF diagnosis during the pre-index period
Other known causes of ILD include conditions such as systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjögren disease, and hypersensitivity pneumonitis (ICD-9-CM codes 135, 237.7, 272.7, 277.3, 277.8, 446.21, 446.4, 495, 500-505, 506.4, 508.1, 508.8, 516.0, 516.1, 516.32-516.37, 516.2, 516.8, 516.9, 517.0, 517.2, 517.8, 518.3, 555, 710.0, 710.0-710.4, 714.0, 714.81, 720, and 759.5, or ICD-10-CM equivalent codes)
With ≥ 1 prescription for nintedanib prior to the index date
With ≥ 1 prescription for pirfenidone prior to or on the index date