Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain

Boehringer Ingelheim172 enrolled

Overview

The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.

Study Type

OBSERVATIONAL

Enrollment

172

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

L - Antineoplastic and immunomodulating agentsDRUG

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agentsDRUG

L01 - Antineoplastic agents

L01X - Other antineoplastic agentsDRUG

L01X - Other antineoplastic agents

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is at least 18 years old * The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management \[5\] * The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local Summary of Product Characteristics (SmPC) Exclusion Criteria: \- Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.

Locations (1)

Dynamic solutions

Barcelona, Spain

Outcomes

Primary Outcomes

Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))

The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))

The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Secondary Outcomes

The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation

The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Duration of the Disease

Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With Emphysema

The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

L01XE - Protein kinase inhibitors

L01XE31 - NintedanibDRUG

L01XE31 - Nintedanib

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern

The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern

The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®

The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy

The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy

The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy

The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Demographic Baseline Characteristics - 6-minute Walk Test

The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit

The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea

The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations

The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments

The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.

The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.

The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)

The distribution of patients across different lung function categories based on the reimbursement threshold (FVC \>80%, 50-80%, and \<50%).

Time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.