Idiopathic Pulmonary FibrosisNCT03958071

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

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 40 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: Nintedanib, Pirfenidone and Untreated Cohort
How many people: 13,264 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2019to 31 May 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

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)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Plymouth Meeting
Plymouth, Pennsylvania, 19462

Other trials in United States

About this study

Official title: Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US

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
Being tested: Nintedanib, Pirfenidone, Untreated Cohort
Medical subject headings: Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NintedanibDrug
Nintedanib initiators
PirfenidoneDrug
Pirfenidone initiators
Untreated CohortOther
Untreated

Study groups in NCT03958071
Study group	Role	What they receive
Subjects with Idiopathic Pulmonary Fibrosis		Not described Receives: Drug: Nintedanib; Drug: Pirfenidone; Other: Untreated Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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. Backward selection was applied to develop a reduced model, only retaining covariates with p<0.1 after forcing age at index, gender, geographic region, BMI, CCI, and Chronic obstructive pulmonary disease (COPD) into the model.
Odds presented for key patient characteristics. Odd ratio of >1 indicates increased odds of receiving treatment.
Measured: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201931 May 2019

First posted21 May 2019
Study start1 Feb 2019
Primary completion31 May 2019
Study completion31 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 13,264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03958071
Sponsor's protocol ID: 1199-0375
Status last verified: Nov 2021
First submitted: 20 May 2019
Last updated: 15 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US
ClinicalTrials.gov ID: NCT03958071
Acronym / sponsor ID: 1199-0375
Conditions: Idiopathic Pulmonary Fibrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 13,264 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Feb 2019 (actual)
Primary completion: 31 May 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 21 May 2019 (actual)
Results: Posted 17 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Subjects with Idiopathic Pulmonary Fibrosis	–	Drug: Nintedanib, Drug: Pirfenidone, Other: Untreated Cohort

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NintedanibNintedanib initiators	Drug	Subjects with Idiopathic Pulmonary Fibrosis
PirfenidonePirfenidone initiators	Drug	Subjects with Idiopathic Pulmonary Fibrosis
Untreated CohortUntreated	Other	Subjects with Idiopathic Pulmonary Fibrosis

Primary outcome

Baseline Patient Characteristics: Age
Time frame: 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 for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Baseline Patient Characteristics: Sex
Time frame: 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 for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Baseline Patient Characteristics: BMI
Time frame: 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.
Baseline Patient Characteristics: Charlson Comorbidity Index (CCI)
Time frame: 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 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 Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline
Time frame: 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 t-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.
Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline
Time frame: 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-test for means of continuous variables, Wilcoxon signed tank test for medians of continuous variables, and Chi-square test for categorical variables.

1 secondary outcome

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

Results and safety

Results posted to the registry on 17 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib	347	347
Pirfenidone	423	423
Untreated	12,494	12,494

Primary outcome: Baseline Patient Characteristics: Age

Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).. Mean (Standard Deviation). Unit: years

Measure	Nintedanib n = 347	Pirfenidone n = 423	Untreated n = 12494
Value	71.6 (6.7)	72.1 (6.8)	70.9 (8.9)

Nintedanib vs Pirfenidone: Absolute standardized differences (ASD): -0.1027, p = 0.2810, t-test, 2 sided
Nintedanib vs Untreated: Absolute standardized differences (ASD): -0.0780, p = 0.1421, t-test, 2 sided
Pirfenidone vs Untreated: Absolute standardized differences (ASD): 0.0159, p = 0.0048, t-test, 2 sided

Population analysed: Includes all patients with an Idiopathic pulmonary fibrosis (IPF) diagnosis from Oct 1, 2013 to Oct 31, 2018. Data derived from IQVIA's GE Centricity EMR (Electronic medical records) data. The EMR consisted of patient data from ambulatory care records in the US, representing the US population receiving healthcare in the ambulatory setting.

Primary outcome: Baseline Patient Characteristics: Sex

Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).. Count of participants. Unit: Participants

Measure	Nintedanib n = 347	Pirfenidone n = 423	Untreated n = 12493
Male	234	281	6179
Female	113	142	6314

Nintedanib vs Pirfenidone: Absolute standardized differences (ASD): 0.0214, p = 0.7681, Chi-squared
Nintedanib vs Untreated: Absolute standardized differences (ASD): 0.3710, p <.0001, Chi-squared
Pirfenidone vs Untreated: Absolute standardized differences (ASD): 0.3490, p <.0001, Chi-squared

Primary outcome: Baseline Patient Characteristics: BMI

Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).. Mean (Standard Deviation). Unit: kilogram/height in meters squared(kg/m²)

Measure	Nintedanib n = 347	Pirfenidone n = 423	Untreated n = 12494
Value	29.5 (6.4)	30.1 (5.8)	28.6 (6.5)

Nintedanib vs Pirfenidone: Absolute standardized differences (ASD): -0.1257, p = 0.1659, t-test, 2 sided
Nintedanib vs Untreated: Absolute standardized differences (ASD): 0.1566, p = 0.0112, t-test, 2 sided
Pirfenidone vs Untreated: Absolute standardized differences (ASD): 0.3019, p <.0001, t-test, 2 sided

Primary outcome: Baseline Patient Characteristics: Charlson Comorbidity Index (CCI)

Time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).. Mean (Standard Deviation). Unit: Score on a scale

Measure	Nintedanib n = 347	Pirfenidone n = 423	Untreated n = 12494
Value	0.71 (1.0)	0.79 (1.1)	1.09 (1.4)

Nintedanib vs Pirfenidone: Absolute standardized differences (ASD): -0.0209, p = 0.3260, t-test, 2 sided
Nintedanib vs Untreated: Absolute standardized differences (ASD): -0.2694, p <.0001, t-test, 2 sided
Pirfenidone vs Untreated: Absolute standardized differences (ASD): -0.2352, p <.0001, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Nintedanib	0 of 0	0 of 0
Pirfenidone	0 of 0	0 of 0
Untreated	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Related trials for Idiopathic Pulmonary Fibrosis

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Patient Characteristics: Age (time frame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03958071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.