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
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Layout table for eligibility information
Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population will consist of the following three mutually exclusive cohorts:
Nintedanib initiators, consisting of adult IPF patients who newly initiated nintedanib treatment
Pirfenidone initiators, consisting of adult IPF patients who newly initiated pirfenidone treatment
Untreated cohort, consisting of adult IPF patients without any prescription for antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone)
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
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer‐ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.