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

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ClinicalTrials.gov Identifier: NCT03281200
Recruitment Status : Completed
First Posted : September 13, 2017
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: L - Antineoplastic and immunomodulating agents Drug: L01 - Antineoplastic agents Drug: L01X - Other antineoplastic agents Drug: L01XE - Protein kinase inhibitors Drug: L01XE31 - Nintedanib

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Study Type : Observational
Actual Enrollment : 172 participants
Observational Model: Other
Time Perspective: Retrospective
Official 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.
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018


Group/Cohort Intervention/treatment
Anatomical main group: Drug: L - Antineoplastic and immunomodulating agents
L - Antineoplastic and immunomodulating agents

Therapeutic subgroup Drug: L01 - Antineoplastic agents
L01 - Antineoplastic agents

Pharmacological subgroup Drug: L01X - Other antineoplastic agents
L01X - Other antineoplastic agents

Chemical subgroup Drug: L01XE - Protein kinase inhibitors
L01XE - Protein kinase inhibitors

Chemical substance Drug: L01XE31 - Nintedanib
L01XE31 - Nintedanib
Other Name: OVEF




Primary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

  2. 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. ]
    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).

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

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

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

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

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

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

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

  10. 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. ]
    The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.

  11. 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. ]
    The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.

  12. 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. ]
    The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.

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

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

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

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281200


Locations
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Spain
Dynamic solutions
Barcelona, Spain, 08029
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03281200     History of Changes
Other Study ID Numbers: 1199-0295
First Posted: September 13, 2017    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action