Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Effectiveness study (incl. comparative)
Study drug and medical condition

Name of medicine

OFEV

Medical condition to be studied

Idiopathic pulmonary fibrosis
Interstitial lung disease

Additional medical condition(s)

SSc-associated ILD
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

500
Study design details

Main study objective

The primary objective is to characterize the long-term treatment outcome of nintedanib for IPF/SSc-ILD/PF-ILD population regarding the disease course under the clinical practice in Taiwan.

Outcomes

(to be analyzed per cohort of IPF, SSc-ILD, or PF-ILD) 1. Annual percentage of decline from baseline in FVC (%) 2. Annual decline from baseline in DLco (%) 3. Annual decline from baseline in resting and exercise SpO2 (%), 1. Time to first acute exacerbation of IPF, or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment 2. Annual change from baseline in SGRQ (for IPF) or K-BILD (for other ILDs) 3. Annual change from baseline in CAT 4. Annual change from baseline in 6MWT 5. Annual change from baseline in Berlin questionnaire 6. Change from baseline in quantification of biomarkers 7. Mortality

Data analysis plan

Descriptive analyses will be performed to summarize patients’ baseline characteristics, lung/liver function, the time to exacerbation for IPF/ILD worsening, and the results of questionnaires, etc. Continuous variables include number, mean, median, standard deviation (SD), range (minimum and maximum value), and 95% confidence intervals (CI). Categorical variables will be reported as frequency and percentage. Besides, comparative analysis for baseline characteristics will be conducted between nintedanib/non-nintedanib cohorts.