Study type

Study type

Non-interventional study

Scope of the study

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

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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

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.

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.