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 Overview
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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.

Official Title
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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.

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: L - Antineoplastic and immunomodulating agents
* Drug: L01 - Antineoplastic agents
* Drug: L01X - Other antineoplastic agents
* Drug: L01XE - Protein kinase inhibitors
* Drug: L01XE31 - Nintedanib


Participation Criteria
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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) Exclusion Criteria: - Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anatomical main group:<br> | Drug: L - Antineoplastic and immunomodulating agents<br>* L - Antineoplastic and immunomodulating agents<br>|
| Therapeutic subgroup<br> | Drug: L01 - Antineoplastic agents<br>* L01 - Antineoplastic agents<br>|
| Pharmacological subgroup<br> | Drug: L01X - Other antineoplastic agents<br>* L01X - Other antineoplastic agents<br>|
| Chemical subgroup<br> | Drug: L01XE - Protein kinase inhibitors<br>* L01XE - Protein kinase inhibitors<br>|
| Chemical substance<br> | Drug: L01XE31 - Nintedanib<br>* L01XE31 - Nintedanib<br>* Other names: OVEF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation | The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented. | 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 | 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). | 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 | The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented. | 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 | The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented. | 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 | The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented. | 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® | The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented. | 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 | The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented. | 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 | The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented. | 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 | The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented. | 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 | The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented. | 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 | The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented. | 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 | The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented. | 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 | The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented. | 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 | The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented. | 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. | The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented. | 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. | The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented. | 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) | The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%). | From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days. |