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Table 1 Patient demographics and baseline characteristics in reversible and non-reversible patients at screening

From: Efficacy of umeclidinium/vilanterol according to the degree of reversibility of airflow limitation at screening: a post hoc analysis of the EMAX trial

Characteristic

ITT (N = 2425)

Reversible (N = 625)

Non-reversible (N = 1799)

Age, years, mean (SD)

64.6 (8.5)

63.5 (8.4)

65.0 (8.5)

Female, n (%)

988 (41)

200 (32)

788 (44)

No maintenance medication during run-in, n (%)

749 (31)

250 (40)

499 (28)

Moderate COPD exacerbation in prior yeara, n (%)

393 (16)

84 (13)

309 (17)

Duration of COPD, years, mean (SD)

8.3 (6.6)

8.4 (6.0)

8.3 (6.8)

Post-salbutamol FEV1, mL, mean (SD)

1595 (511)

1455 (478)

1502 (529)

Post-salbutamol % predicted FEV1, mean (SD)

55.4 (12.7)

56.0 (12.0)

55.3 (13.0)

Rescue salbutamol, puffs/day, mean (SD)

2.2 (2.5)

2.7 (2.9)

2.0 (2.3)

GOLD spirometric gradeb, n (%)

 2

1569 (65)

416 (67)

1153 (64)

 3

851 (35)

207 (33)

644 (36)

 % reversibility to salbutamol, mean (SD)

10.5 (13.1)

26.2 (13.3)

5.0 (7.4)

 CAT score, mean (SD)

19.2 (6.0)

20.0 (6.5)

18.9 (6.0)

 BDI score, mean (SD)

7.0 (1.9)

7.0 (2.0)

7.0 (1.8)

 E-RS total score

10.6 (5.7)

11.7 (5.9)

10.2 (5.6)

 SGRQ score, mean (SD)

44.7 (16.2)

46.3 (17.3)

44.1 (15.7)

  1. Reversibility was defined as an increase in post-salbutamol FEV1 of ≥ 12% and ≥ 200 mL; anumber of exacerbations requiring oral or systemic corticosteroids and/or antibiotics (moderate) in 12 months prior to screening (patients with > 1 moderate exacerbation or with a severe exacerbation [requiring hospitalisation] were excluded); ban additional 4 (< 1%) patients with GOLD grade 1 were randomised (reversible n = 2; non-reversible n = 2)
  2. BDI, Baseline Dyspnoea Index; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms-COPD; FEV1, forced expiratory volume in 1 s; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ITT, intent-to-treat; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire