Efficacy end-points for treatment with montelukast, eformoterol and fluticasone
| Run-in | Washout 1 | Washout 2 | Montelukast | Eformoterol | Fluticasone | M versus EF | M versus FP | EF versus FP | |
| Clinical variables | |||||||||
| FEV1 % pred | 76.1±11.9 | 73.6±15.50 | 73.9±15.3 | 76.2±18.0 | 77.0±13.6 | 81.8±13.9 | 0.4 | 0.0002 | 0.0002 |
| PD20 methacholine µmol# | 0.39 (0.3–0.5) | 0.49 (0.33–0.71) | 0.43 (0.31–0.59) | 0.57 (0.40–0.81) | 0.46 (0.32–0.67) | 1.26 (0.86–1.86) | 0.4 | <0.0001 | 0.0008 |
| QoL score (Marks et al. 12), range 0–4 least to most impaired | 0.63±0.09 | NA | NA | 0.59±0.09 | 0.400.08 | 0.41±0.14 | 0.001 | 0.005 | 0.9 |
| ACQ Score 1, range 0–6 best to worst | 1.95±0.75 | 2.05±0.94 | 1.8±0.82 | 1.56±0.92 | 1.17±0.55 | 1.05±0.75 | 0.02 | <0.0001 | 0.3 |
| Patient GAAC, range 0–100, worst to best | 54.8±24.8 | 48.0±25.4 | 51.5±21.9 | 63.9±23.8 | 71.1±21.3 | 71.4±21.7 | 0.08 | 0.03 | 0.8 |
| Diary variables | |||||||||
| Mean a.m. PEF L·min−1 | 424±119 | 409±121 | 415±134 | 428±125 | 453±121 | 468±134 | <0.0001 | <0.0001 | 0.08 |
| Day symptom intensity score, range 0–4, best to worst | 2.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (0.0–1.6) | 1.0 (0.0–1.0) | 0.0 (0.0–1.0) | 0.049 | 0.6 | 0.08 |
| Night symptom intensity score, range 0–4, best to worst | 1.0 (1.0–2.0) | 1.0 (0.0–2.0) | 1.0 (0.0–2.0) | 1.0 (0.0–1.5) | 0.0 (0.0–1.0) | 0.0 (0.0–1.0) | <0.0001 | 0.01 | 0.08 |
| Symptom-free days % | 0 (0–0) | 0 (0–13) | 0 (0–14) | 0 (0–34) | 23 (0–47) | 26 (0–67) | 0.01 | <0.0001 | 0.2 |
| Daytime salbutamol use puffs·day−1 | 3.0 (1.0–5.5) | 2.0 (0.0–4.0) | 2.0 (0.0–3.5) | 0.0 (0.0–3.0) | 0.0 (0.0–1.0) | 0.0 (0.0–2.0) | 0.01 | 0.05 | 0.1 |
| Night salbutamol use puffs·day−1 | 2.0 (0.0–2.0) | 1.3 (0.0–2.0) | 0.3 (0.0–2.0) | 0.3 (0.0–2.0) | 0.0 (0.0–0.0) | 0.0 (0.0–1.0) | <0.0001 | 0.02 | 0.04 |
| Salbutamol-free days % | 0 (0–13) | 0 (0–16) | 13 (0–20) | 30 (0–49) | 40 (20–67) | 37 (2–73) | 0.008 | 0.03 | 0.3 |
| DACS, range 1–5, worst to best | 3.0 (3.0–4.0) | 3.0 (3.0–4.0) | 3.0 (3.0–4.0) | 3.5 (3.0–4.0) | 4.0 (3.0–4.0) | 4.0 (3.0–4.0) | 0.01 | 0.4 | 0.2 |
Data are presented as mean±sd or median (interquartile range), unless otherwise indicated. FEV1: forced expiratory volume in one second; % pred: per cent predicted; PD20: provocative dose of methacholine causing a 20% fall in FEV1; QoL: quality of life; ACQ: asthma control questionnaire; GAAC: global assessment of asthma control; PEF: peak expiratory flow; DACS: daily asthma control score. #: geometric mean (95% confidence interval). p-values for montelukast versus eformoterol were from randomised crossover analysis; p-values for montelukast versus fluticasone and eformoterol versus fluticasone used end-of-treatment values for paired t-test (parametric variables) or Wilcoxon signed-rank test (nonparametric variables).