TABLE 1.
Secondary efficacy, safety and pharmacokinetics end-points
| Efficacy | Safety | Pharmacokinetics |
| Change from baseline in LCI for patients with FEV1 >60% pred values at screening after 4 weeks of treatment | Percentage of patients with treatment-emergent AEs up to day 36 | Concentration of the analyte in plasma at time t following dose N (Ct.N) |
| Change from baseline in CFQ-R after 4 weeks of treatment | Pre-dose concentration measured for dose N (Cpre.N) | |
| Change from baseline in CASA-Q after 4 weeks of treatment | Area under the concentration–time curve of the analyte in plasma until t hours after dose N (AUC0–t,N) |
LCI: lung clearance index; FEV1: forced expiratory volume in 1 s; AE: adverse event; CFQ-R: CF Questionnaire – Revised; CASA-Q: Cough and Sputum Assessment Questionnaire.