Methods
Trial design5
- Subjects had an ILD other than IPF, diagnosed by the investigator according to their usual clinical practice, reticular abnormality with traction bronchiectasis (with or without honeycombing) of >10% extent on HRCT, FVC ≥45% predicted and DLco ≥30%–<80% predicted.
- Subjects met ≥1 of the following criteria for ILD progression in the 24 months before screening, despite management as deemed appropriate in clinical practice:
- Subjects were randomized 1:1 to receive nintedanib 150 mg bid or placebo, stratified by HRCT pattern (usual interstitial pneumonia [UIP]-like fibrotic pattern or other fibrotic patterns). For each subject, the trial consisted of two parts. Part A was a 52-week treatment period. Part B was a variable treatment period beyond 52 weeks, during which subjects continued on blinded randomized treatment. The first database lock was performed after the last subject had completed 52 weeks.
Analyses
- In pre-specified analyses, we assessed:
- Proportion of subjects with absolute and relative declines in FVC >5% and >10% predicted at week 52
- Time to absolute decline in FVC ≥10% predicted or death up to first database lock
- Time to first investigator-reported acute exacerbation of ILD or death up to first database lock.