Contents
Methods
InPedILD trial design
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EoT, end of treatment. R, randomisation.
Dosing of nintedanib
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*Patients with weight <13.5 kg were excluded from the trial. Dose was adjusted during treatment based on weight.
†Dose reductions (to the next dose) and treatment interruptions were permitted to manage adverse events.
Key inclusion criteria
- Age 6–17 years
- Evidence of fibrosing ILD on HRCT
- FVC ≥25% predicted
- Clinically significant disease
- Fan score7 ≥3:
- Symptomatic, normal resting room air saturation but abnormal saturation with sleep or exercise; symptomatic, abnormal resting room air saturation; symptomatic with pulmonary hypertension
- Evidence of clinical progression:
- Relative decline in FVC ≥10% predicted; relative decline in FVC of 5–10% predicted with worsening symptoms; worsening fibrosis on HRCT; other measures of clinical worsening attributed to progressive pulmonary fibrosis.
Co-primary endpoints
- Area under plasma concentration-time curve at steady state (AUCT,SS) at weeks 2 and 26 (i.e., week 2 of nintedanib treatment).
- Proportion of patients with treatment-emergent adverse events at week 24.