Methods
Trial design2
- Subjects were enrolled who 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).
- The L-PF questionnaire and PF-IQOLS were completed at baseline and week 52:
Analyses
- In pre-specified analyses, we assessed changes from baseline at week 52 in the L-PF total score, impact score, symptoms score and symptoms domain scores, and the PF-IQOLS summary score.
- Changes in the L-PF symptoms dyspnea domain score and the L-PF symptoms cough domain score were secondary endpoints. Changes in all other scores were further endpoints.
- Data were analyzed using a mixed model for repeated measures, with fixed effects for baseline, HRCT pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction and random effect for subject.