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Table 4 Time to FEV 1 increase of ≥12% and ≥200 ml from baseline, ITT population

From: Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids

  VI 25 mcg OD (N = 115) SAL 50 mcg BD (N = 116) Placebo (N = 116)
Day 1
N 115 116 113
Number (%) patients achieving threshold increasea 65 (57) 59 (51) 36 (32)
Hazard ratio vs. placebo 2.358 1.750 NA
95% CI (1.542 – 3.606) (1.136 – 2.696)
Day 84
N 101 100 96
Number (%) patients achieving threshold increasea 57 (56) 54 (54) 51 (53)
Hazard ratio vs. placebo 0.993 0.911 NA
95% CI (0.659 – 1.495) (0.604 – 1.374)
  1. a0–2 hours post-dose.
  2. Cox proportional hazards model with covariates of baseline FEV1, sex, age, region and treatment.
  3. BD: twice-daily; CI: confidence interval; FEV1: forced expiratory volume in one second; ITT: intent-to-treat; n: number of patients used in analysis; NA: not applicable; OD: once-daily; SAL: salmeterol; VI: vilanterol.