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

NCT03281200 | Completed Results FDA Drug

• 1 other identifier: 1199-0295
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• 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 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.

• 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 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 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.

Study Arms (5)

Anatomical main group:

Drug: L - Antineoplastic and immunomodulating agents

Therapeutic subgroup

Drug: L01 - Antineoplastic agents

Pharmacological subgroup

Drug: L01X - Other antineoplastic agents

Chemical subgroup

Drug: L01XE - Protein kinase inhibitors

Chemical substance

Drug: L01XE31 - Nintedanib

Interventions

L - Antineoplastic and immunomodulating agents DRUG

L - Antineoplastic and immunomodulating agents

Anatomical main group:

L01 - Antineoplastic agents DRUG

L01 - Antineoplastic agents

Therapeutic subgroup

L01X - Other antineoplastic agents DRUG

L01X - Other antineoplastic agents

Pharmacological subgroup

L01XE - Protein kinase inhibitors DRUG

L01XE - Protein kinase inhibitors

Chemical subgroup

L01XE31 - Nintedanib DRUG

L01XE31 - Nintedanib

Also known as: OVEF

Chemical substance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Dynamic solutions

Barcelona, 08029, Spain

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Immunomodulating Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: October 24, 2017
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: August 1, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-06

Locations

ES (1)