Investigating Trends in Quality of Life in Patients with Idiopathic Pulmonary Fibrosis (IPF) Under Treatment with Nintedanib (QUALIFY IPF)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  QoL evaluation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB
• 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)
• Estimated number of subjects:
  240

Study design details

• Main study objective:
  To evaluate the HRQoL changes of IPF patients treated in current clinical practice in Greece with nintedanib over a 52-weeks period
• Outcomes:
  Mean change from baseline in HRQoL in patients under treatment with nintedanib over 52 weeks follow-up period, Change from baseline of dyspnoea burden as measured by mMRC questionnaire Mean change from baseline of cough burden as measured by the cough - VAS Percentage of adhered patients to nintedanib treatment Mean change from baseline of anxiety as measured by the GAD-7 questionnaire. Percentage of patients that use LTOT over the 52 weeks follow up period
• Data analysis plan:
  The nature of the statistical analyses will be exploratory and descriptive.