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Table 1 Demographic and clinical characteristics at baseline

From: Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study

 

Men n = 2557

Women n = 805

P value

Age, years

65.2 ± 7.7

62.6 ± 7.6

< 0.001

Duration of COPD, years

7.1 ± 5.2

7.7 ± 5.9

0.004

Current smoker, n (%)

946 (37.0)

387 (48.1)

< 0.001

Estimated number of pack years

43.6 ± 22.5

36.0 ± 18.5

< 0.001

Severity of COPD (GOLD 2015), n (%)

 Low risk and more symptoms (Group B)

589 (23.0)

233 (28.9)

0.002

 High risk and more symptoms (Group D)

1945 (76.1)

569 (70.7)

Severity of airflow limitation (GOLD 2011–2014), n (%)

 Moderate (GOLD 2)

804 (31.4)

319 (39.6)

< 0.001

 Severe (GOLD 3)

1506 (58.9)

448 (55.7)

 Very severe (GOLD 4)

222 (8.7)

35 (4.3)

Pre-bronchodilator FEV1, L

1.1 ± 0.3

0.8 ± 0.2

< 0.001

Post-bronchodilator FEV1, L

1.3 ± 0.3

1.0 ± 0.3

< 0.001

Post-bronchodilator FEV1, % predicted

43.5 ± 9.5

45.8 ± 9.0

< 0.001

Post-bronchodilator FEV1 reversibility, % of baseline value

22.2 ± 16.0

22.9 ± 16.2

0.233

Post-bronchodilator FEV1/FVC, %

40.9 ± 9.9

43.7 ± 9.5

< 0.001

Number of COPD exacerbations in the previous year, n (%)

 1

2094 (81.9)

616 (76.5)

0.002

 ≥ 2

461 (18.0)

188 (23.4)

CAT scorea

16.5 ± 7.0

17.7 ± 7.1

< 0.001

mMRCb, n (%)

 Grade 0–1

4 (0.2)

1 (0.1)

0.954

 Grade 2

1838 (71.9)

574 (71.3)

 Grade 3

660 (25.8)

211 (26.2)

 Grade 4

55 (2.2)

19 (2.4)

BMI (kg/m2)

25.7 ± 4.9

26.3 ± 6.0

0.003

ICS use, n (%)

1382 (54.0)

511 (63.5)

< 0.001

LAMA use, n (%)

1535 (60.0)

502 (62.4)

0.238

LABA use, n (%)

1651 (64.6)

606 (75.3)

< 0.001

  1. Demographic and clinical characteristics at baseline for the randomized set has been presented. Data are presented as mean ± SD unless otherwise stated. P-values are based on t-tests for continuous variables and chi-square tests (or Fisher’s exact test as appropriate) for categorical variables. aon a scale of 0–40, with higher scores indicating worse health status; bon a scale of 0–4, with higher scores indicating more severe dyspnea
  2. BMI body mass index, CAT COPD assessment test, COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, GOLD Global Initiative for Chronic Obstructive Lung Disease, ICS inhaled corticosteroid, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist, mMRC modified Medical Research Council, SD standard deviation