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. 2022 Jun 9;59(6):2102184. doi: 10.1183/13993003.02184-2021

TABLE 1.

Baseline characteristics

Sequence A: placebo–tiotropium (n=46) Sequence B: tiotropium–placebo (n=44)
Male 22 (48) 12 (27)
Age (years) 59.3±13.0 62.0±11.3
Smoking status
 Current/ex-smoker 21 (46) 16 (37)
 Smoking history (pack-years)# 6.0±5.7 6.0±5.3
Asthma 11 (24) 11 (25)
Medical conditions (n ) 3.8±2.4 4.0±2.1
Body mass index (kg·m−2) 28.3±7.7 28.8±9.8
Ethnic origin
 European 29 (63) 25 (57)
 Pasifika 6 (13) 7 (16)
 Māori 8 (17) 10 (23)
 Other 3 (7) 2 (5)
Exacerbations in past year (n) 2.4±1.4 3.2±1.6
Spirometry
 Pre-bronchodilator
  FEV1 (L) 1.78±0.53 1.67±0.45
  FEV1 (% pred) 59.4±14.2 64.2±17.2
  FVC (L) 3.02±0.83 2.82±0.67
  FVC (% pred) 75.3±15.1 81.6±16.9
 Post-bronchodilator
  FEV1 (L) 1.88±0.55 1.76±0.50
  FEV1 (% pred) 63.1±14.4 68.3±18.6
  FVC (L) 3.06±0.83 2.87±0.72
  FVC (% pred) 77.5±14.9 84.2±16.5
SGRQ domain scores
 Symptoms 52.8±20.9 45.4±24.6
 Activity 40.3±24.7 37.6±22.0
 Impacts 28.3±15.6 24.3±16.3
 Total 35.9±16.9 31.7±17.5
6MWT (m) 536.0±69.8 500.6±99.2
Peripheral blood cells
 White blood cells (×109 mL−1) 7.7±2.2 8.2±2.4
 Neutrophils (×109 mL−1) 4.8±2.1 5.1±2.1
 Eosinophils (×109 mL−1) 0.22±0.15 0.28±0.23
Sputum cells
 Total cells (×109 mL−1) 15.2±23.9 21.1±34.5
 Neutrophils (×109 mL−1) 14.2±23.2 20.2±34.4
 Eosinophils (×109 mL−1) 0.04±0.18 0.18±0.48
 Bronchial epithelial cells (×109 mL−1) 0.12±0.24 0.08±0.16
Respiratory drugs
 Any 33 (72) 29 (66)
 Inhaled anticholinergic
  Short- or long-acting 0 (0) 0 (0)
 Inhaled β2-agonists
  Short-acting, alone 9 (17) 4 (7)
  Long-acting, alone 0 (0) 0 (0)
 ICS
  Alone 2 (4) 5 (11)
  Mucolytic agent 5 (11) 1 (2)
  Leukotriene receptor antagonist 0 (0) 0 (0)
 Combination inhalers
  LABA/ICS 5 (11) 1 (2)
 LABA combined with ICS in two separate inhalers 20 (43) 17 (39)
Aetiology
 Idiopathic 36 (78) 31 (70)
 Inflammatory bowel disease 3 (7) 2 (5)
 Pink disease (infantile mercury exposure) 0 (0) 1 (2)
 Post-infective 5 (11) 6 (14)
 Post-tuberculous 1 (2) 4 (9)
 Primary ciliary dyskinesia 1 (2) 0 (0)

Data are presented as mean±sd or n (%), unless otherwise stated. FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; SGRQ: St George's Respiratory Questionnaire; 6MWT: 6-min walk test distance; ICS: inhaled corticosteroids; LABA: long-acting β-agonist. #: among current and ex-smokers only.