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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-24

Study Completion Date

2018-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anatomical main group:

L - Antineoplastic and immunomodulating agents

Intervention Type DRUG

L - Antineoplastic and immunomodulating agents

Therapeutic subgroup

L01 - Antineoplastic agents

Intervention Type DRUG

L01 - Antineoplastic agents

Pharmacological subgroup

L01X - Other antineoplastic agents

Intervention Type DRUG

L01X - Other antineoplastic agents

Chemical subgroup

L01XE - Protein kinase inhibitors

Intervention Type DRUG

L01XE - Protein kinase inhibitors

Chemical substance

L01XE31 - Nintedanib

Intervention Type DRUG

L01XE31 - Nintedanib

Interventions

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L - Antineoplastic and immunomodulating agents

Intervention Type DRUG

L01 - Antineoplastic agents

Intervention Type DRUG

L01X - Other antineoplastic agents

Intervention Type DRUG

L01XE - Protein kinase inhibitors

Intervention Type DRUG

L01XE31 - Nintedanib

Intervention Type DRUG

Other Intervention Names

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OVEF

Eligibility Criteria

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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)