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Completed

NCT Number: NCT03281200

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dynamic solutions

Barcelona, 08029, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L - Antineoplastic and immunomodulating agents

Drug

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

Drug

L01 - Antineoplastic agents

L01X - Other antineoplastic agents

Drug

L01X - Other antineoplastic agents

L01XE - Protein kinase inhibitors

Drug

L01XE - Protein kinase inhibitors

L01XE31 - Nintedanib

Drug

L01XE31 - Nintedanib

Other names: OVEF

Primary outcomes

  1. Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))

    Time frame: 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.

  2. Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))

    Time frame: 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 outcomes

  1. The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation

    Time frame: 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.

  2. The Clinical Baseline Characteristics - Duration of the Disease

    Time frame: 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).

  3. The Clinical Baseline Characteristics - Percentage of Patients With Emphysema

    Time frame: 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.

  4. The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern

    Time frame: 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.

  5. The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern

    Time frame: 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.

  6. The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®

    Time frame: 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.

  7. The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy

    Time frame: 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.

  8. The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy

    Time frame: 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.

  9. The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy

    Time frame: 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.

  10. The Demographic Baseline Characteristics - 6-minute Walk Test

    Time frame: 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.

  11. The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit

    Time frame: 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.

  12. The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea

    Time frame: 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.

  13. The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations

    Time frame: 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.

  14. The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments

    Time frame: 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.

  15. Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.

    Time frame: 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.

  16. Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.

    Time frame: 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.

  17. Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)

    Time frame: 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%).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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