Non-Interventional study (NIS) Collecting Experiences For IPF in Taiwan (NICEFIT)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Evaluation of patient-reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  OFEV
• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE31) nintedanib

  nintedanib
• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Short description of the study population:
  idiopathic pulmonary fibrosis (IPF) patients
• 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:
  100

Study design details

• Study design:
  non-interventional multi-center study
• Main study objective:
  The primary objective is to characterize the IPF population in Taiwan with regard to their clinical course under clinical practice conditions in Taiwan. The secondary objectives are to understand the clinical characteristics and quality of life of IPF population in Taiwan.
• Setting:
  Clinical practice in Taiwan.
• Outcomes:
  Annual change of lung function. (i.e. FVC, DLco, SpO2, TLC and IC), AE-IPF, SGRQ, CAT, 6MWT and mortality
• Data analysis plan:
  A Data Management Plan (DMP) and Statistical Analysis Plan (SAP) will be prepared to describe all processes, variables, and specifications for data collection, cleaning, validation, and analyses. The study is essentially descriptive. All patients who have signed the informed consent and fulfilled study criteria will be included in the main analysis. The variables included in the study objectives will be analyzed with measures of central tendency (mean and median), variability/dispersion (standard deviation and interquartile ranges), distributions of absolute and relative frequencies, and 95% confidence intervals, as appropriate. Mortality will be analyzed by Kaplan-Meier estimates.For analysis of primary and secondary outcomes (spirometry tests, SGRQ, CAT, and 6MWT), imputation will be permitted, if deemed appropriate and on a case-by-case basis, depending on the extent and distribution of missing values, and will be described in the SAP.
• Summary results:
  Conclusion ; This first long-term, real-world study provides the efficacy and safety outcomes of IPF patients following the routine management in Taiwan and finds out that the decline in lung functions is lessened following the ; treatment of anti-fibrotic drugs. However, the incidence of acute exacerbation is still high in comparison with Western countries and other Asian studies. The ways to prevent acute exacerbation and improve the quality of life in IPF patients warrant further consideration.