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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

Tracking Information
First Submitted Date September 11, 2017
First Posted Date September 13, 2017
Results First Submitted Date June 6, 2019
Results First Posted Date August 1, 2019
Last Update Posted Date August 1, 2019
Actual Study Start Date October 24, 2017
Actual Primary Completion Date June 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: September 11, 2017)
distribution of patients across different lung function categories (%FVC and DLCO serving as surrogate markers for IPF severity) of IPF patients at the time of treatment initiation with nintedanib (OFEV®) in routine clinical practice [ Time Frame: 1 day ]
Change History Complete list of historical versions of study NCT03281200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 6, 2019)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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%).
Original Secondary Outcome Measures
 (submitted: September 11, 2017)
  • frequency of each method of diagnosis [ Time Frame: 1 day ]
  • mean duration of the disease from diagnosis to treatment initiation [ Time Frame: 1 day ]
  • frequency of patients with associated emphysema [ Time Frame: 1 day ]
  • frequency of patients with UIP pattern (according to international guideline, Raghu et al. 2011) [ Time Frame: 1 day ]
  • OFEV® treatment initiation date of each dose [ Time Frame: 1 day ]
  • OFEV® treatment initiation frequency of each dose [ Time Frame: 1 day ]
  • Patient demographics (age, male and female, race) [ Time Frame: 1 day ]
  • Physical examination ( height, weight, BMI, mean distance of the 6 minutes walking [ Time Frame: 1 day ]
  • smoking status (current smokers, former smokers and never smokers) [ Time Frame: 1 day ]
  • breathlessness grade mMRC [ Time Frame: 1 day ]
  • concomitant medication (active substance, dose, initiation date, indication) [ Time Frame: 1 day ]
  • Mean Number of exacerbations due to IPF in the previous year [ Time Frame: 1 day ]
  • Mean frequency of exacerbations due to IPF in the previous year [ Time Frame: 1 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain
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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Idiopathic Pulmonary Fibrosis
Intervention
  • Drug: L - Antineoplastic and immunomodulating agents
    L - Antineoplastic and immunomodulating agents
  • Drug: L01 - Antineoplastic agents
    L01 - Antineoplastic agents
  • Drug: L01X - Other antineoplastic agents
    L01X - Other antineoplastic agents
  • Drug: L01XE - Protein kinase inhibitors
    L01XE - Protein kinase inhibitors
  • Drug: L01XE31 - Nintedanib
    L01XE31 - Nintedanib
    Other Name: OVEF
Study Groups/Cohorts
  • Anatomical main group:
    Intervention: Drug: L - Antineoplastic and immunomodulating agents
  • Therapeutic subgroup
    Intervention: Drug: L01 - Antineoplastic agents
  • Pharmacological subgroup
    Intervention: Drug: L01X - Other antineoplastic agents
  • Chemical subgroup
    Intervention: Drug: L01XE - Protein kinase inhibitors
  • Chemical substance
    Intervention: Drug: L01XE31 - Nintedanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019)
172
Original Estimated Enrollment
 (submitted: September 11, 2017)
175
Actual Study Completion Date June 7, 2018
Actual Primary Completion Date June 7, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03281200
Other Study ID Numbers 1199-0295
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators Not Provided
PRS Account Boehringer Ingelheim
Verification Date June 2019