临床试验/NCT03281200

NCT03281200已完成不适用

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.

Boehringer Ingelheim1 个研究点分布在 1 个国家目标入组 172 人开始时间: 2017年10月24日最近更新: 2019年8月1日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 172
试验地点: 1
主要终点: Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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)

排除标准

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

研究组 & 干预措施

Anatomical main group:

干预措施: L - Antineoplastic and immunomodulating agents (Drug)

Therapeutic subgroup

干预措施: L01 - Antineoplastic agents (Drug)

Pharmacological subgroup

干预措施: L01X - Other antineoplastic agents (Drug)

Chemical subgroup

干预措施: L01XE - Protein kinase inhibitors (Drug)

Chemical substance

干预措施: L01XE31 - Nintedanib (Drug)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

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 - 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 - 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 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.)
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®(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(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(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.(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.(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(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(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(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(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(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(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)(From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.)

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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