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

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

	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 increase^a	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)	NA
Day 84
N	101	100	96
Number (%) patients achieving threshold increase^a	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)	NA

^a0–2 hours post-dose.
Cox proportional hazards model with covariates of baseline FEV₁, sex, age, region and treatment.
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.

ISSN: 1477-5751