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 (BROAD)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

• Name of medicine:
  OFEV
• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Short description of the study population:
  Idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib (OFEV®) with respect to their clinical profile based on real-world data from Spanish pulmonology Services.; ; Patients could be included in the study if all of the following criteria were met:; 1. The patient is at least 18 years old; 2. The patient has IPF diagnosis according to 2011 ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management; 3. The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up to end of data collection date, according to the approved local SmPC.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Idiopathic pulmonary fibrosis (IPF) patients
• Estimated number of subjects:
  175

Study design details

• Main study objective:
  The primary objective of the study is to describe the distribution of patients across different lung function categories (%FVC and 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.
• Outcomes:
  The primary outcome of the study is the 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. To describe demographic and clinical baseline characteristics of IPF patients at time of treatment initiation with nintedanib (OFEV®).
• Data analysis plan:
  Since the study is essentially descriptive the variables included in the study objectives will be analysed with measures of central tendency (mean and median), variability/dispersion (standard deviation and interquartile ranges), absolute and relative frequencies, and ranges. 95% confidence intervals will be provided as appropriate.