Primary and secondary outcomes at baseline and 8 weeks after treatment
| Placebo | Fluticasone | Montelukast | ||||
|---|---|---|---|---|---|---|
| Day 0 | Day 56 | Day 0 | Day 56 | Day 0 | Day 56 | |
| Induced sputum data are expressed as geometric mean (SD) except neutrophils which are expressed as mean (SD). Clinical parameters data are expressed as mean (SD). | ||||||
| Symptoms score as in table 1. | ||||||
| *p values adjusted for baseline values for comparisons between treatment arms: fluticasone v placebo, p = 0.004; fluticasone v montelukast, p = 0.008; montelukast v placebo, p = 0.9. | ||||||
| †Pre-bronchodilator values. | ||||||
| ‡p values adjusted for baseline values for comparisons between treatment arms: fluticasone v placebo, p = 0.02; fluticasone v montelukast, p = 0.01; montelukast v placebo, p = 0.9. | ||||||
| Induced sputum | ||||||
| Total cell count (×106/g) | 2.0 (2.6) | 2.5 (2.3) | 3.9 (2.1) | 4.9 (1.8) | 3.1 (2.3) | 4.6 (2.3) |
| Eosinophils (%) | 15.4 (2.4) | 7.8 (4.2) | 11.9 (2.3) | 1.7 (5.1)* | 10.7 (2.3) | 6.9 (3.8) |
| Neutrophils (%) | 27.4 (20) | 28.7 (23) | 28.9 (21) | 35.3 (28) | 24.2 (15) | 36.0 (27) |
| Clinical parameters | ||||||
| Symptoms score | 22.5 (4.5) | 28.3 (5.1) | 23.2 (6.4) | 30.5 (4.3) | 25.6 (5.5) | 28.5 (5.9) |
| Salbutamol (puffs/day) | 2.7 (1.9) | 2.1 (1.5) | 3.3 (2.6) | 0.8 (0.9) | 3.3 (3.1) | 2.5 (2.7) |
| FEV1 (l)† | 2.4 (0.8) | 2.4 (0.9) | 2.6 (0.9) | 3.0 (0.9)‡ | 2.8 (0.7) | 2.8 (0.9) |