Clinical 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
Official title: Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 13264
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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


Eligibility 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

Primary outcomes:
measure: Baseline Patient Characteristics: Age
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
measure: Baseline Patient Characteristics: Sex
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
measure: Baseline Patient Characteristics: BMI
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
measure: Baseline Patient Characteristics: Charlson Comorbidity Index (CCI)
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
measure: Baseline Patient Characteristics: Number of Participants Using Inhaled Corticosteroids at Baseline
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
measure: Baseline Patient Characteristics: Number of Participants Using Proton Pump Inhibitors at Baseline
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Secondary outcomes:
measure: Odds Ratio of Receiving Treatment (Nintedanib or Pirfenidone) vs no Treatment
timeFrame: Baseline characteristics were recorded 12 months pre-index event (pre-treatment).
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Plymouth Meeting
state: Pennsylvania
Study officials:
References: