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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03281200
• Date of registration: 11/09/2017
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain
• Scientific 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.
• Date of first enrolment: October 24, 2017
• Target sample size: 172
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03281200
• Study type: Observational

Countries of recruitment

Spain

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: L - Antineoplastic and immunomodulating agents

Drug: L01XE - Protein kinase inhibitors

Drug: L01 - Antineoplastic agents

Drug: L01X - Other antineoplastic agents

Drug: L01XE31 - Nintedanib

Primary Outcome(s)

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.]

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.]

Secondary Outcome(s)

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 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.]

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 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 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 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 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 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.]

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 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 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.]

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 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 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 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 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.]

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.]

Secondary ID(s)

1199-0295

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03281200