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

Completed

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

• Registration Number: NCT03281200
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-10-24
• Primary Completion: 2018-06-07
• Study Completion: 2018-06-07
• Status Verified: 2019-06
• Results First Submitted: 2019-06-06
• Results First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Results First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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)

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Exclusion Criteria

• Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapeutic subgroup	L01 - Antineoplastic agents	-
Pharmacological subgroup	L01X - Other antineoplastic agents	-
Chemical subgroup	L01XE - Protein kinase inhibitors	-
Chemical substance	L01XE31 - Nintedanib	-
Anatomical main group:	L - Antineoplastic and immunomodulating agents	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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 - 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).
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 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 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.
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 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 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 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.
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%).

Trial Locations

Locations (1)

Dynamic solutions; 🇪🇸 Barcelona, Spain