IPF Italian observational study (FIBRONET)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The study aims to provide information on disease characteristics and treatment modalities (at enrolment) and on disease progression, HRQoL and health care sector-related costs according to the Italian National Health Service (INHS) point of view (during 12 months of observation).
• Outcomes:
  To describe the clinical course during 12 months of observation, in terms of:• symptoms • lung function (VC, FVC, FEV1, TLC, DLCO, pO2, pCO2)• exercise tolerance (6-minute walk distance test). Description of characteristics of IPF patients in terms of:key demographic data,IPF risk factors,comorbiditie,IPF disease severity and manifestation,methods used for IPF diagnosis,IPF treatment modalities,to describe the frequency of exacerbations,to describe HRQoL variation, measured with SGRQ, EuroQol 5-dimension 5-level descriptive system and EQ VAS,to describe health care sector-related costs
• Data analysis plan:
  The statistical analysis will be performed on all evaluable patients who enter the study and meet the inclusion criteria. Patients with missing values will not be excluded from the analysis, their data will not be replaced, frequency of missing data will be given for all analyzed variables. Descriptive analysis will be composed of means, medians, quantiles, proportions (with their respective 95% confidence intervals, CI) and contingency tables according to the nature of the variables. As a dispersion measurements, the standard deviation and the interquartile range will be calculated. All events during follow-up will be described as incidence rates with 95% CI.