TABLE 1.
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.