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

NCT03958071 | Completed Results

• 1 other identifier: 1199-0375
• Study Type: observational
• Target: 13,264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (6)

• Baseline Patient Characteristics: Age

  IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic age for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

• Baseline Patient Characteristics: Sex

  IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. The patient characteristic sex for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

• Baseline Patient Characteristics: BMI

  The patient characteristic Body mass index (BMI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

• Baseline Patient Characteristics: Charlson Comorbidity Index (CCI)

  IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized HIPPA compliant database populated with patient data from ambulatory care records. Charlson Comorbidity Index (CCI) for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts. The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

• Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline

  IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with inhaled corticosteroids for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

• Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline

  IQVIA's GE Centricity Electronic medical records database was used for this study. This is an anonymized Health Insurance Portability and Accountability Act of 1996 (HIPPA) compliant database populated with patient data from ambulatory care records. Treatment with Proton pump inhibitors for Idiopathic Pulmonary Fibrosis (IPF) patients at 12-month pre-treatment (baseline) was compared between each of the cohorts (nintedanib vs. pirfenidone, nintedanib vs. untreated, pirfenidone vs. untreated), differences are presented in absolute standardized differences (ASD), differences were tested using t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Secondary Outcomes (1)

• Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment

  Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Study Arms (1)

Subjects with Idiopathic Pulmonary Fibrosis

Drug: Nintedanib; Drug: Pirfenidone; Other: Untreated Cohort

Interventions

Nintedanib DRUG

Nintedanib initiators

Subjects with Idiopathic Pulmonary Fibrosis

Pirfenidone DRUG

Pirfenidone initiators

Subjects with Idiopathic Pulmonary Fibrosis

Untreated Cohort OTHER

Untreated

Subjects with Idiopathic Pulmonary Fibrosis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of the following three mutually exclusive cohorts: 1. Nintedanib initiators, consisting of adult IPF patients who newly initiated nintedanib treatment 2. Pirfenidone initiators, consisting of adult IPF patients who newly initiated pirfenidone treatment 3. Untreated cohort, consisting of adult IPF patients without any prescription for antifibrotic treatment (i.e., no prescription for nintedanib nor pirfenidone)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Plymouth Meeting

Plymouth, Pennsylvania, 19462, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib; pirfenidone

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations common to retrospective database studies: high proportion of missing data and it is possible that patients who received out-of-system care and treatments were not fully captured in the data.

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 21, 2019
• Study Start: February 1, 2019
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: November 15, 2021
• Results First Posted: December 17, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)