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.

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 Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: L - Antineoplastic and immunomodulating agents; Drug: L01 - Antineoplastic agents; Drug: L01X - Other antineoplastic agents; Drug: L01XE - Protein kinase inhibitors; Drug: L01XE31 - Nintedanib

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08029
    • Dynamic solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 175 IPF patients from 35 Pulmonology Services in Spain are planned to be included in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anatomical main group:	Drug: L - Antineoplastic and immunomodulating agents; L - Antineoplastic and immunomodulating agents
Therapeutic subgroup	Drug: L01 - Antineoplastic agents; L01 - Antineoplastic agents
Pharmacological subgroup	Drug: L01X - Other antineoplastic agents; L01X - Other antineoplastic agents
Chemical subgroup	Drug: L01XE - Protein kinase inhibitors; L01XE - Protein kinase inhibitors
Chemical substance	Drug: L01XE31 - Nintedanib; L01XE31 - Nintedanib; Other Names: OVEF

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): June 7, 2018
• Study Completion (Actual): June 7, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nintedanib; Antineoplastic Agents; Protein Kinase Inhibitors
• Other Study ID Numbers: 1199-0295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No