A Prospective Observational Registry to describe the disease course and outcomes of Idiopathic Pulmonary Fibrosis patients in a real-world clinical setting (PROOF-R)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective observational registry

Study drug and medical condition

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

Population studied

• 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:
  Pregnant women
• Estimated number of subjects:
  750

Study design details

• Main study objective:
  To describe the disease course and outcomes in IPF patients.
• Outcomes:
  Endpoints to describe disease progression, time to:a- first occurrence of decrease ≥ 10% in percent predicted FVCb- first occurrence of a decrease ≥ 15% in percent predicted Hgb corrected DLCOc- death, a-IPF treatment drugs name(s), initial dose, dose changes, drug discontinuation, duration of dose reduction/interruption, lung transplantationb-Change in QoL scorec- ADRs and SADRs, which were defined as occurring after the first dose and within 28 days after the last dose of registry treatment.d-Consultation of HCPs and the relation of these consultations with IPF (treatment).
• Data analysis plan:
  All data will be summarized using descriptive statistics: number of patients, means, medians, standard deviations (SD), minimums, and maximums for continuous variables, and frequencies and percentages for discrete variables.