Clinical trial 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
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-09-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Secondary outcomes:
measure: The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Duration of the Disease
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Demographic Baseline Characteristics - 6-minute Walk Test
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
measure: Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
timeFrame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dynamic solutions
Study officials:
References: