Investigating idiopathic pulmonary fibrosis in Greece (INDULGE IPF)

Study type

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Registry

Study drug and medical condition

• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To gain further knowledge on the characteristics, management, progression and outcomes of patients with IPF as treated under real -world,clinical practice conditions in Greece.
• Outcomes:
  To gain further knowledge on the characteristics, management, progression and outcomes of patients with IPF as treated under real -world,clinical practice conditions in Greece. This registry documents management and treatment of IPFpatients in real-world clinical practice. One objective of this registry is to document drugs used for IPF.
• Data analysis plan:
  The nature of the statistical analyses will be exploratory and descriptive. Continuous variables will be listed as median with interquartile and other percentages, and as mean value with standard deviation (SD), along with minimum and maximum values (depending on the underlying distribution). Categorical values will be listed as absolute and relative frequencies. All events during follow up will be described as incidence rates with 95% confidence interval (CI). Stratified analyses will be performed among newly diagnosed patients (< 6 months) as well as patients that were diagnosed in the past (>= 6 months). In case of conflicting results those of the newly diagnosed will be the decisive. Due to limited number of patients and population heterogeneity, no comparison between treatments can be done and no causal relationship conclusion can be derived (no hypothesis testing). Statistical analyses will be performed with IBM SPSS Statistics (Version 19.0).