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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281200

Enrollment

172

Registered

2017-09-13

Start date

2017-10-24

Completion date

2018-06-07

Last updated

2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Brief summary

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.

Interventions

DRUGL - Antineoplastic and immunomodulating agents

L - Antineoplastic and immunomodulating agents

DRUGL01 - Antineoplastic agents

L01 - Antineoplastic agents

DRUGL01X - Other antineoplastic agents

L01X - Other antineoplastic agents

DRUGL01XE - Protein kinase inhibitors

L01XE - Protein kinase inhibitors

DRUGL01XE31 - Nintedanib

L01XE31 - Nintedanib

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	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.
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	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.

Secondary

Measure	Time frame	Description
The Clinical Baseline Characteristics - Percentage of Patients With Emphysema	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.
The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.
The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.
Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The distribution of patients across different lung function categories based on the reimbursement threshold (FVC \>80%, 50-80%, and \<50%).
The Demographic Baseline Characteristics - 6-minute Walk Test	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
The Clinical Baseline Characteristics - Duration of the Disease	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.	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).

Countries

Spain

Participant flow

Recruitment details

Non-interventional study based on medical charts was conducted in approximately 35 pulmonology services in Spanish hospitals. Idiopathic pulmonary fibrosis (IPF) patients were characterized at the time of nintedanib initiation. Analysis of this report was performed using the data collected in the database from 21October2017 up to 31January2018.

Pre-assignment details

All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be analyzed if any one of the specific entry criteria were not met.

Participants by arm

Arm	Count
Total Patients With IPF The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.	172
Total	172

Baseline characteristics

Characteristic	Total Patients With IPF
Age, Continuous	71.0 Years STANDARD_DEVIATION 8.1
Race/Ethnicity, Customized Arab	1 Participants
Race/Ethnicity, Customized Asiatic	1 Participants
Race/Ethnicity, Customized Caucasian	170 Participants
Sex/Gender, Customized Female	40 Particpants
Sex/Gender, Customized Male	131 Particpants
Sex/Gender, Customized No data	1 Particpants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	10 / 172
other Total, other adverse events	38 / 172
serious Total, serious adverse events	13 / 172

Outcome results

Primary

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.