NCT03958071

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

Completed Results posted Last updated 15 November 2021

What this trial tests

trial testing Nintedanib in Idiopathic Pulmonary Fibrosis in 13,264 participants. Completed in 31 May 2019.

Timeline

1 February 2019

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	13,264
Start date	1 February 2019
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Nintedanib (NINTEDANIB) — full drug profile →
• Pirfenidone — full drug profile →
• Untreated Cohort

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

40 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline Patient Characteristics: Age Primary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

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 f

Group	Value	95% CI
Nintedanib	71.6	± 6.7
Pirfenidone	72.1	± 6.8
Untreated	70.9	± 8.9

Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment Secondary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Odds ratio of receiving nintedanib or pirfenidone vs. no antifibrotic treatment, adjusting for patient characteristics; to identify baseline characteristics that drive initiation of a treatment while minimizing prescription bias. Logistic regression models were developed to assess the odds. Baseline patient characteristics that were sufficiently populated, had ASD \>10% or p-value \<0.05, and were agreed upon as important variables to include, were included as covariates for a full model. Linearity of age was confirmed before including it as a continuous variable in one version of the model.

Age

Group	Value	95% CI
Overall Population	1.022	1.012 – 1.032

Gender

Group	Value	95% CI
Overall Population	0.490	0.419 – 0.574

BMI category: Overweight

Group	Value	95% CI
Overall Population	1.359	1.113 – 1.660

BMI category: Obese

Group	Value	95% CI
Overall Population	1.833	1.483 – 2.265

BMI category: Very obese

Group	Value	95% CI
Overall Population	1.638	1.281 – 2.096

Comorbidities: COPD

Group	Value	95% CI
Overall Population	0.581	0.457 – 0.739

Comorbidities: Heart failure

Group	Value	95% CI
Overall Population	0.449	0.299 – 0.675

Comorbidities: Stroke

Group	Value	95% CI
Overall Population	0.449	0.226 – 0.889

Baseline Patient Characteristics: Sex Primary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

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 f

Group	Value	95% CI
Nintedanib	234
Pirfenidone	281
Untreated	6179
Nintedanib	113
Pirfenidone	142
Untreated	6314

Baseline Patient Characteristics: BMI Primary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

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.

Group	Value	95% CI
Nintedanib	29.5	± 6.4
Pirfenidone	30.1	± 5.8
Untreated	28.6	± 6.5

Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) Primary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

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 o

Group	Value	95% CI
Nintedanib	0.71	± 1.0
Pirfenidone	0.79	± 1.1
Untreated	1.09	± 1.4

Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline Primary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

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

Group	Value	95% CI
Nintedanib	125
Pirfenidone	134
Untreated	3311

Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline Primary · Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

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

Group	Value	95% CI
Nintedanib	113
Pirfenidone	133
Untreated	3141

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.