Fibrosing interstitial lung disease
Conditions
Brief summary
"AUCT,SS based on sampling at steady state using rich sampling (at Week 2 in Part A and at Week 28 in Part B) in participants from 6 years to less than 18 years and sparse sampling (at Week 2 of Part A) in participants younger than 6 years ", Occurrence of a treatment-emergent adverse event (Yes/No) up to Week 26
Detailed description
Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest at Week 26 and Week 52, Absolute change from baseline in height [cm] at Week 26 and Week 52, Absolute change from baseline in PedsQL™ at Week 26 and Week 52, Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial, Time to first respiratory-related hospitalisation [days] over the whole trial, Time to first acute ILD exacerbation or death [days] over the whole trial, Time to death [days] over the whole trial, Acceptability based on number/size of tablets at Week 2 and Week 26, Acceptability based on the use of the dispenser at Week 2 and Week 26, Absolute change from baseline in FVC [% predicted] at Week 26 and Week 52 (applicable to participants ≥6 years), Absolute change from baseline in 6-min walk distance [m] at Week 26 and Week 52 (applicable to participants ≥6 years)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "AUCT,SS based on sampling at steady state using rich sampling (at Week 2 in Part A and at Week 28 in Part B) in participants from 6 years to less than 18 years and sparse sampling (at Week 2 of Part A) in participants younger than 6 years ", Occurrence of a treatment-emergent adverse event (Yes/No) up to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest at Week 26 and Week 52, Absolute change from baseline in height [cm] at Week 26 and Week 52, Absolute change from baseline in PedsQL™ at Week 26 and Week 52, Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial, Time to first respiratory-related hospitalisation [days] over the whole trial, Time to first acute ILD exacerbation or death [days] over the whole trial, Time to death [days] over the whole trial, Acceptability based on number/size of tablets at Week 2 and Week 26, Acceptability based on the use of the dispenser at Week 2 and Week 26, Absolute change from baseline in FVC [% predicted] at Week 26 and Week 52 (applicable to participants ≥6 years), Absolute change from baseline in 6-min walk distance [m] at Week 26 and Week 52 (applicable to participants ≥6 years) | — |