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Table 1 Baseline demographics and clinical characteristics (randomized set)

From: Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study

Characteristics

Indacaterol/glycopyrronium 110/50 μg o.d.

Salmeterol/fluticasone 50/500 μg b.i.d.

(n = 1680)

(n = 1682)

Age, years

64.6 ± 7.89

64.5 ± 7.70

Men, n (%)

1299 (77.3)

1258 (74.8)

COPD severitya, n (%)

 Moderate, GOLD 2

560 (33.3)

563 (33.5)

 Severe, GOLD 3

973 (57.9)

981 (58.3)

 Very severe, GOLD 4

133 (7.9)

124 (7.4)

 High risk and more symptoms (Group D)

1265 (75.3)

1249 (74.3)

Current smokers, n (%)

664 (39.5)

669 (39.8)

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

 1

1355 (80.7)

1355 (80.6)

  ≥ 2

324 (19.3)

325 (19.3)

SGRQ-C total scoreb

47.3 (15.8)

47.2 (15.9)

Post-bronchodilator FEV1, L

1.2 ± 0.34

1.2 ± 0.35

Post-bronchodilator FEV1, % predicted

44.0 ± 9.48

44.1 ± 9.43

Post-bronchodilator FEV1/FVC, %

41.7 ± 9.82

41.5 ± 9.89

  1. Data presented as mean ± SD, unless otherwise specified; aCOPD severity is based on the GOLD 2015 criteria [27]; GOLD 2011 [28]; bOn a scale of 0–100, with higher scores indicating worse health status; the MCID is a change of 4 units; On a scale of 0–4, with higher scores indicating more severe dyspnea; On a scale of 0–40, with higher scores indicating worse health status
  2. b.i.d., twice daily; 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; MCID, minimum clinically important difference; mMRC, modified Medical Research Council; o.d., once daily; SD, standard deviation; SGRQ-C, St. George’s Respiratory Questionnaire for COPD