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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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ClinicalTrials.gov Identifier: NCT03958071
Recruitment Status : Completed
First Posted : May 21, 2019
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: Nintedanib Drug: Pirfenidone Other: Untreated Cohort

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Study Type : Observational
Actual Enrollment : 13264 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019


Group/Cohort Intervention/treatment
Subjects with Idiopathic Pulmonary Fibrosis Drug: Nintedanib
Nintedanib initiators

Drug: Pirfenidone
Pirfenidone initiators

Other: Untreated Cohort
Untreated




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.

  4. 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.


  5. Baseline Patient Characteristics, Treatment During Baseline: Inhaled Corticosteroids [ 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.


  6. Baseline Patient Characteristics, Treatment During Baseline: Proton Pump Inhibitors [ 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.



Secondary Outcome Measures :
  1. Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958071


Locations
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United States, Pennsylvania
Plymouth Meeting
Plymouth, Pennsylvania, United States, 19462
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03958071    
Other Study ID Numbers: 1199-0375
First Posted: May 21, 2019    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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'.
URL: https://trials.boehringer-ingelheim.com
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pirfenidone
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents