Table. 2—

Efficacy end-points for treatment with montelukast, eformoterol and fluticasone

Run-inWashout 1Washout 2MontelukastEformoterolFluticasoneM versus EFM versus FPEF versus FP
Clinical variables
 FEV1 % pred76.1±11.973.6±15.5073.9±15.376.2±18.077.0±13.681.8±13.90.40.00020.0002
 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<0.00010.0008
 QoL score (Marks et al. 12), range 0–4 least to most impaired0.63±0.09NANA0.59±0.090.400.080.41±0.140.0010.0050.9
 ACQ Score 1, range 0–6 best to worst1.95±0.752.05±0.941.8±0.821.56±0.921.17±0.551.05±0.750.02<0.00010.3
 Patient GAAC, range 0–100, worst to best54.8±24.848.0±25.451.5±21.963.9±23.871.1±21.371.4±21.70.080.030.8
Diary variables
 Mean a.m. PEF L·min−1424±119409±121415±134428±125453±121468±134<0.0001<0.00010.08
 Day symptom intensity score, range 0–4, best to worst2.0 (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)0.0490.60.08
 Night symptom intensity score, range 0–4, best to worst1.0 (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)<0.00010.010.08
 Symptom-free days %0 (0–0)0 (0–13)0 (0–14)0 (0–34)23 (0–47)26 (0–67)0.01<0.00010.2
 Daytime salbutamol use puffs·day−13.0 (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)0.010.050.1
 Night salbutamol use puffs·day−12.0 (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)<0.00010.020.04
 Salbutamol-free days %0 (0–13)0 (0–16)13 (0–20)30 (0–49)40 (20–67)37 (2–73)0.0080.030.3
 DACS, range 1–5, worst to best3.0 (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)0.010.40.2
  • 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).