Trial Outcomes & Findings for Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain (NCT NCT03281200)

NCT ID: NCT03281200

Last Updated: 2019-08-01

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 172 participants
• Primary outcome timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
• Results posted on: 2019-08-01

Participant Flow

Non-interventional study based on medical charts was conducted in approximately 35 pulmonology services in Spanish hospitals. Idiopathic pulmonary fibrosis (IPF) patients were characterized at the time of nintedanib initiation. Analysis of this report was performed using the data collected in the database from 21October2017 up to 31January2018.

All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be analyzed if any one of the specific entry criteria were not met.

Participant milestones

Measure	Total Patients With IPF The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Overall Study STARTED	172
Overall Study COMPLETED	172
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Age, Continuous	71.0 Years STANDARD_DEVIATION 8.1 • n=172 Participants
Sex/Gender, Customized Male	131 Particpants n=172 Participants
Sex/Gender, Customized Female	40 Particpants n=172 Participants
Sex/Gender, Customized No data	1 Particpants n=172 Participants
Race/Ethnicity, Customized Caucasian	170 Participants n=172 Participants
Race/Ethnicity, Customized Asiatic	1 Participants n=172 Participants
Race/Ethnicity, Customized Arab	1 Participants n=172 Participants

PRIMARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

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.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) Mild IPF: FVC ≥ 70%	57.0 Percentage of Patients (%)
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) Moderate IPF: FVC between 50% and 69%	38.4 Percentage of Patients (%)
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity)) Severe IPF: FVC < 50%	4.7 Percentage of Patients (%)

PRIMARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.Include only those patients DLCO value who has been answered in the case report form (CRF).

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.

Outcome measures

Measure	Total Patients With IPF n=153 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)) Mild IPF: DLCO ≥ 50%	42.5 Percentage of Patients (%)
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)) Moderate IPF: DLCO between 35% and 49%	35.3 Percentage of Patients (%)
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)) Severe IPF: DLCO < 35%	22.2 Percentage of Patients (%)

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation	70.1 Years Standard Deviation 8.1

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

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).

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Duration of the Disease	1.5 Years Standard Deviation 3.8

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With Emphysema No	84.3 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Emphysema Yes	15.7 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern No	13.4 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern Yes	30.8 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern No data	55.8 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern No	9.9 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern Yes	89.0 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern No data	1.2 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV® 150 mg/12 h	88.4 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV® 100 mg/12 h	11.0 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV® No data	0.6 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=160 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy	77.1 Kilogram (Kg) Standard Deviation 13.2

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=159 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy	164.5 Centimeters (cm) Standard Deviation 8.9

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=159 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy	28.4 Kilogram/ meter^2 (kg/m^2) Standard Deviation 3.8

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=136 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Demographic Baseline Characteristics - 6-minute Walk Test	421.7 Meter (m) Standard Deviation 118.6

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit Never smoker	33.1 Percentage of Participants
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit Former smoker	64.0 Percentage of Participants
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit Active smoker	2.9 Percentage of Participants

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea No	5.2 Percentages of Partients
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea Yes	93.0 Percentages of Partients
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea No data	1.7 Percentages of Partients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations No	84.9 Percentages of patients
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations Yes	11.6 Percentages of patients
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations No data	3.5 Percentages of patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments No	20.3 Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments Yes	79.7 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Hypertension	45.9 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Dyslipidaemia	42.4 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Gastroesophageal reflux	25.6 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Diabetes mellitus	19.8 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Emphysema	15.7 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Cardiovascular disease	15.7 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Obstructive sleep apnoea	11.6 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Pulmonary hypertension	5.8 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Lung cancer	1.7 Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation. Pulmonary infection	1.2 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.	41.9 Percentages of Patients

SECONDARY outcome

Timeframe: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.

Population: All enrolled patients who met the selection criteria.

The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).

Outcome measures

Measure	Total Patients With IPF n=172 Participants The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC) Mild IPF: FVC > 80%	33.1 Percentages of Patients Interval 26.3 to 40.8
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC) Moderate IPF: FVC between 50% and 80%	62.2 Percentages of Patients Interval 54.5 to 69.4
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC) Severe IPF: FVC < 50%	4.7 Percentages of Patients Interval 2.2 to 9.3

Adverse Events

Total Patients With IPF

Serious events: 13 serious events

Other events: 38 other events

Deaths: 10 deaths

Serious adverse events

Measure	Total Patients With IPF n=172 participants at risk The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Cardiac disorders Acute coronary syndrome	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Cardiac disorders Cardiac failure congestive	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Gastrointestinal disorders Diarrhoea	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
General disorders Death	1.2% 2/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Hepatobiliary disorders Hepatotoxicity	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Infections and infestations Pneumonia pneumococcal	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Investigations Weight decreased	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	1.7% 3/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events
Vascular disorders Hypertensive crisis	0.58% 1/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events

Other adverse events

Measure	Total Patients With IPF n=172 participants at risk The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.
Gastrointestinal disorders Diarrhoea	22.1% 38/172 • From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days Patients who enrolled in the study and met the selection criteria used for reporting adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER