TABLE 2.
Inclusion criteria | Exclusion criteria |
Male or female, aged ≥12 years at screening | Acute upper or lower respiratory tract infection ≤4 weeks prior to randomisation |
Diagnosis of CF (positive sweat chloride ≥60 mEq·L−1, or genotype with two identifiable mutations and ≥1 clinical phenotypic feature of CF) | Pulmonary exacerbation requiring the use of antibiotics or oral corticosteroids ≤4 weeks prior to randomisation |
FEV1 (according to Global Lung Initiative) ≥40 and ≤90% pred at screening and pre-dose at visit 2 |
CF: cystic fibrosis; FEV1: forced expiratory volume in 1 s.