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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281200
• Other study ID #: 1199-0295
• Status: Completed
• Start date: October 24, 2017
• Est. completion date: June 7, 2018

Study information

• Verified date: June 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• L - Antineoplastic and immunomodulating agents
L - Antineoplastic and immunomodulating agents
• L01 - Antineoplastic agents
L01 - Antineoplastic agents
• L01X - Other antineoplastic agents
L01X - Other antineoplastic agents
• L01XE - Protein kinase inhibitors
L01XE - Protein kinase inhibitors
• L01XE31 - Nintedanib
L01XE31 - Nintedanib

Locations

Country	Name	City	State
Spain	Dynamic solutions	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
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.	From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

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