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Table 2 Baseline demographic and clinical characteristics by treatment, study and overall

From: The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies

 

ATTAIN

AUGMENT COPD

Pooled analysis sample

Characteristic

Aclidinium 400 μg (n = 269)a

Placebo (n = 273)a

Aclidinium 400 μg (n = 337)a

Placebo (n = 331)a

Aclidinium 400 μg (n = 583)b

Placebo (n = 578)b

All patients (n = 1161)b

Age, years, mean (SD)

62.9 (8.4)

62.0 (8.0)

64.4 (8.7)

63.5 (8.9)

63.7 (8.6)

62.8 (8.5)

63.2 (8.6)

Male, n (%)

182 (67.7)

189 (69.2)

188 (55.8)

175 (52.9)

356 (61.1)

347 (60.0)

703 (60.6)

Caucasian, n (%)

257 (95.5)

260 (95.2)

314 (93.2)

316 (95.5)

548 (94.0)

552 (95.5)

1100 (94.7)

BMI, kg/m2, mean (SD)

27.0 (4.8)

26.6 (5.2)

27.5 (5.3)

27.7 (5.6)

27.3 (5.1)

27.2 (5.5)

27.2 (5.3)

Current smoker, n (%)

148 (55.0)

144 (52.8)

171 (50.7)

169 (51.1)

303 (52.0)

300 (51.9)

603 (51.9)

Smoking history, pack-years, mean (SD)

41.7 (21.1)

38.9 (18.3)

52.0 (26.1)

53.4 (28.5)

47.1 (23.4)

47.1 (25.8)

47.1 (24.6)

Post-bronchodilator FEV1, L, mean (SD)c

1.6 (0.5)

1.6 (0.5)

1.5 (0.5)

1.6 (0.5)

1.6 (0.5)

1.6 (0.5)

1.6 (0.5)

Post-bronchodilator FEV1, % predicted, mean (SD)c

56.2 (12.2)

56.6 (12.8)

53.0 (13.3)

52.6 (13.3)

54.5 (12.9)

54.2 (13.3)

54.4 (13.1)

% bronchial reversibility (SD)

11.3 (12.9)

12.3 (15.7)

19.1 (16.5)

18.4 (15.2)

15.7 (15.6)

15.7 (15.7)

15.7 (15.6)

Number of exacerbations in previous year, mean (SD)

0.5 (0.7)

0.4 (0.9)

0.3 (0.8)

0.3 (0.6)

0.4 (0.8)

0.3 (0.7)

0.4 (0.8)

  1. aPatients from the ITT population
  2. bPatients from the pooled subpopulation: ITT population (N = 1210) with data available for GOLD classification (43 patients were excluded due to missing GOLD data and a further 6 patients due to missing baseline E-RS data)
  3. cAt screening visit
  4. BMI, body mass index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FEV 1 , forced expiratory volume in 1 s; GOLD, Global initiative for chronic Obstructive Lung Disease; ITT, intent-to-treat; SD standard deviation