Trial · 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
NCT03958071, Completed, Boehringer Ingelheim; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03958071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03958071
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03958071
- Status
- Completed
- Enrollment
- 13,264 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Nintedanib, Pirfenidone, Untreated Cohort
- First posted
- 2019-05-21
- Last updated
- 2021-11-15
- Results first posted
- 2020-12-17
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Baseline Patient Characteristics: Age | 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. |
| Primary | Baseline Patient Characteristics: Sex | 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. |
| Primary | Baseline Patient Characteristics: BMI | 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. |
| Primary | Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | 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. |
| Primary | Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | 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. |
| Primary | Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | 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. |
| Secondary | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | 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. 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Patient Characteristics: Age | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. | years | MEAN |
| SECONDARY | Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. | Odds ratio | NUMBER |
| PRIMARY | Baseline Patient Characteristics: Sex | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. One patient from the untreated cohort was missing gender information and is not shown in the table | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Baseline Patient Characteristics: BMI | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. | kilogram/height in meters squared(kg/m²) | MEAN |
| PRIMARY | Baseline Patient Characteristics: Charlson Comorbidity Index (CCI) | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. | Score on a scale | MEAN |
| PRIMARY | Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline | Baseline characteristics were recorded 12 months pre-index event (pre-treatment). | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Patient Characteristics: Age | Nintedanib | 71.6 | Standard Deviation 6.7 | years | |
| Baseline Patient Characteristics: Age | Pirfenidone | 72.1 | Standard Deviation 6.8 | years | |
| Baseline Patient Characteristics: Age | Untreated | 70.9 | Standard Deviation 8.9 | years | |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | Age | 1.022 | 95% Confidence Interval 1.012 to 1.032 | Odds ratio |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | Gender | 0.490 | 95% Confidence Interval 0.419 to 0.574 | Odds ratio |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | BMI category: Overweight | 1.359 | 95% Confidence Interval 1.113 to 1.660 | Odds ratio |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | BMI category: Obese | 1.833 | 95% Confidence Interval 1.483 to 2.265 | Odds ratio |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | BMI category: Very obese | 1.638 | 95% Confidence Interval 1.281 to 2.096 | Odds ratio |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | Comorbidities: COPD | 0.581 | 95% Confidence Interval 0.457 to 0.739 | Odds ratio |
| Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment | Overall Population | Comorbidities: Heart failure | 0.449 | 95% Confidence Interval 0.299 to 0.675 | Odds ratio |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib | 347 | |
| Overall Study | STARTED | Pirfenidone | 423 | |
| Overall Study | STARTED | Untreated | 12,494 | |
| Overall Study | COMPLETED | Nintedanib | 347 | |
| Overall Study | COMPLETED | Pirfenidone | 423 | |
| Overall Study | COMPLETED | Untreated | 12,494 | |
| Overall Study | NOT COMPLETED | Nintedanib | 0 | |
| Overall Study | NOT COMPLETED | Pirfenidone | 0 | |
| Overall Study | NOT COMPLETED | Untreated | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib | 0 | 0 |
| Total, all-cause mortality | Pirfenidone | 0 | 0 |
| Total, all-cause mortality | Untreated | 0 | 0 |
| Total, other adverse events | Nintedanib | 0 | 0 |
| Total, other adverse events | Pirfenidone | 0 | 0 |
| Total, other adverse events | Untreated | 0 | 0 |
| Total, serious adverse events | Nintedanib | 0 | 0 |
| Total, serious adverse events | Pirfenidone | 0 | 0 |
| Total, serious adverse events | Untreated | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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