Baseline demographic and clinical characteristics of patients
| Arm A (active control), oral ciprofloxacin/inhaled colistin (n=105) | Arm B (test treatment), oral ciprofloxacin/inhaled tobramycin (n=118) | |
| Age in years, median (IQR) | 7.45 (1–25.5) | 7.64 (1–35.2) |
| Gender, n (%) | ||
| Female | 53 (50.5) | 54 (45.8) |
| Male | 52 (49.5) | 64 (54.2) |
| Cystic fibrosis genotype, n (%) | ||
| F508del homozygotes | 25 (23.8) | 29 (24.5) |
| F508del compound heterozygotes | 44 (41.9) | 53 (44.9) |
| Other genotype | 36 (34.3) | 36 (30.6) |
| Coinfection with other pathogens at baseline, n (%) | ||
| Staphylococcus aureus | 62 (59) | 63 (53.5) |
| Methicillin-resistant S aureus | 7 (6) | 2 (1.6) |
| Haemophilus influenzae | 10 (9.5) | 12 (10) |
| Streptococcus pneumoniae | 0 | 2 (1.6) |
| Pseudomonas aeruginosa infection, n (%) | ||
| First-ever infection | 57 (54.3) | 64 (54.2) |
| Previously infected | 48 (45.7) | 54 (45.8) |
| FEV1 (% of predicted) | ||
| Mean (±SD) | 93.1 (±23.1) | 91.8 (±19.1) |
| Patients able to perform spirometry, n (%) | 60 (57.1) | 68 (57.6) |
| Age and FEV1 group, n (%) | ||
| ≤5 years | 36 (34.3) | 41 (34.8) |
| >5–12 years, FEV1<70% | 9 (8.6) | 11 (9.3) |
| >5–12 years, FEV1>70% | 32 (30.4) | 35 (29.7) |
| >12 years, FEV1<70% | 5 (4.8) | 5 (4.2) |
| >12 years, FEV1>70% | 23 (21.9) | 26 (22) |
FEV1, forced expiratory volume in 1 s.