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CompletedNCT03281200Updated Aug 1, 2019Results posted

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

An observational study in Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-01.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
172
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients treated with nintedanib within a clinical trial or named-patient program or with any prior treatment of nintedanib.
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
172 participants (actual)
Patient registry
No

Groups and cohorts

  • Anatomical main group:

    Drug: L - Antineoplastic and immunomodulating agents

  • Therapeutic subgroup

    Drug: L01 - Antineoplastic agents

  • Pharmacological subgroup

    Drug: L01X - Other antineoplastic agents

  • Chemical subgroup

    Drug: L01XE - Protein kinase inhibitors

  • Chemical substance

    Drug: L01XE31 - Nintedanib

Interventions

  • DrugL - Antineoplastic and immunomodulating agents

    L - Antineoplastic and immunomodulating agents

  • DrugL01 - Antineoplastic agents

    L01 - Antineoplastic agents

  • DrugL01X - Other antineoplastic agents

    L01X - Other antineoplastic agents

  • DrugL01XE - Protein kinase inhibitors

    L01XE - Protein kinase inhibitors

  • DrugL01XE31 - Nintedanib

    L01XE31 - Nintedanib

    Also known as: OVEF

05

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    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 outcomes

  1. 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.

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

  14. 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.

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

  15. 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.

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

  16. 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.

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

  17. 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%).

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

06

Results

Posted Aug 1, 2019

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.

Participant flow — Overall Study
MilestoneTotal Patients With IPF
Started172
Completed172
Not completed0

Outcome measures

PrimaryPercentage 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentage of Patients (%)
Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
Percentage of Patients (%)Total Patients With IPF
Mild IPF: FVC ≥ 70%57.0
Moderate IPF: FVC between 50% and 69%38.4
Severe IPF: FVC < 50%4.7
PrimaryPercentage 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentage of Patients (%)
Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
Percentage of Patients (%)Total Patients With IPF
Mild IPF: DLCO ≥ 50%42.5
Moderate IPF: DLCO between 35% and 49%35.3
Severe IPF: DLCO < 35%22.2
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Mean · Years
The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
YearsTotal Patients With IPF
The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation70.1 ± 8.1
SecondaryThe 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).

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Mean · Years
The Clinical Baseline Characteristics - Duration of the Disease
YearsTotal Patients With IPF
The Clinical Baseline Characteristics - Duration of the Disease1.5 ± 3.8
SecondaryThe Clinical Baseline Characteristics - Percentage of Patients With Emphysema

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

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
Percentages of PatientsTotal Patients With IPF
No84.3
Yes15.7
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
Percentages of PatientsTotal Patients With IPF
No13.4
Yes30.8
No data55.8
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
Percentages of PatientsTotal Patients With IPF
No9.9
Yes89.0
No data1.2
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
Percentages of PatientsTotal Patients With IPF
150 mg/12 h88.4
100 mg/12 h11.0
No data0.6
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Mean · Kilogram (Kg)
The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
Kilogram (Kg)Total Patients With IPF
The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy77.1 ± 13.2
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Mean · Centimeters (cm)
The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
Centimeters (cm)Total Patients With IPF
The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy164.5 ± 8.9
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Mean · Kilogram/ meter^2 (kg/m^2)
The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
Kilogram/ meter^2 (kg/m^2)Total Patients With IPF
The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy28.4 ± 3.8
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Mean · Meter (m)
The Demographic Baseline Characteristics - 6-minute Walk Test
Meter (m)Total Patients With IPF
The Demographic Baseline Characteristics - 6-minute Walk Test421.7 ± 118.6
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentage of Participants
The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
Percentage of ParticipantsTotal Patients With IPF
Never smoker33.1
Former smoker64.0
Active smoker2.9
SecondaryThe Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea

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

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Partients
The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
Percentages of PartientsTotal Patients With IPF
No5.2
Yes93.0
No data1.7
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of patients
The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
Percentages of patientsTotal Patients With IPF
No84.9
Yes11.6
No data3.5
SecondaryThe 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
Percentages of PatientsTotal Patients With IPF
No20.3
Yes79.7
SecondaryPercentage 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
Percentages of PatientsTotal Patients With IPF
Hypertension45.9
Dyslipidaemia42.4
Gastroesophageal reflux25.6
Diabetes mellitus19.8
Emphysema15.7
Cardiovascular disease15.7
Obstructive sleep apnoea11.6
Pulmonary hypertension5.8
Lung cancer1.7
Pulmonary infection1.2
SecondaryPercentage 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.

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
Percentages of PatientsTotal Patients With IPF
Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.41.9
SecondaryPercentage 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%).

Time frame:
From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
Reported as:
Number · Percentages of Patients
Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
Percentages of PatientsTotal Patients With IPF
Mild IPF: FVC > 80%33.1 (26.3 to 40.8)
Moderate IPF: FVC between 50% and 80%62.2 (54.5 to 69.4)
Severe IPF: FVC < 50%4.7 (2.2 to 9.3)

Adverse events

Collected over From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Total Patients With IPF10/172 (5.8%)13/172 (7.6%)38/172 (22.1%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTotal Patients With IPF
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders3/172
DeathGeneral disorders2/172
Acute coronary syndromeCardiac disorders1/172
Cardiac failure congestiveCardiac disorders1/172
DiarrhoeaGastrointestinal disorders1/172
HepatotoxicityHepatobiliary disorders1/172
Pneumonia pneumococcalInfections and infestations1/172
Weight decreasedInvestigations1/172
Transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/172
PneumothoraxRespiratory, thoracic and mediastinal disorders1/172
Most frequent other events
Most frequent other events
EventTotal Patients With IPF
DiarrhoeaGastrointestinal disorders38/172

Baseline characteristics

All enrolled patients who met the selection criteria.

Age, Continuous
Age, Continuous(Years)Total Patients With IPF
Mean71.0 ± 8.1
Sex/Gender, Customized
Sex/Gender, Customized(Particpants)Total Patients With IPF
Male131
Female40
No data1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Total Patients With IPF
Hispanic or Latino—
Not Hispanic or Latino—
Unknown or Not Reported—
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Total Patients With IPF
Caucasian170
Asiatic1
Arab1
07

Study locations

1 site
  • Dynamic solutions
    Barcelona, 08029, Spain
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 11, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Registry details

Key details

Study ID
NCT03281200
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Oct 24, 2017
Primary completion
Jun 7, 2018
Completion
Jun 7, 2018
Results posted
Aug 1, 2019
Last update
Aug 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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