Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial

Table 1 Patient demographics and baseline characteristics (safety population)

Characteristic	Patients (N = 112)
Age (years), mean (SD)	60.3 (8.1)
Gender (male), n (%)	76 (67.9)
Race (Caucasian/white), n (%)	112 (100.0)
Current smoker, n (%)	74 (66.1)
Smoking history (pack-years), mean (SD)	48.0 (25.0)
COPD duration (years), mean (SD)	8.8 (6.3)
Severity of airflow limitation,^a n (%)
Moderate	80 (71.4)
Severe	32 (28.6)
Post-bronchodilator FEV₁ (L) at screening
Mean (SD)	1.7 (0.5)
% predicted, mean (SD)	56.7 (11.6)
FRC at screening (L)
Mean (SD)	5.0 (1.0)
% predicted, mean (SD)	152.3 (26.0)
Exercise endurance time at baseline^b (s), mean (SD)	485.7 (234.4)
Intensity of dyspnea at isotime at baseline^b (Borg CR-10 scale), mean (SD)	5.7 (2.6)
Lung function variables at baseline,^b mean (SD)
FEV₁ (L)	1.5 (0.5)
% predicted FEV₁	49.7 (14.7)
FVC (L)	3.3 (0.9)
% predicted FVC	88.3 (18.2)
IC (L)	2.2 (0.5)
Whole-body plethysmographic variables at baseline,^b mean (SD)
FRC (L)	5.0 (1.1)
% predicted FRC	151.3 (28.0)
RV (L)	4.0 (1.0)
% predicted RV	179.4 (40.5)
TLC (L)	7.3 (1.3)
% predicted TLC	116.9 (15.6)
sGaw (s^-1kPa^-1)	0.5 (0.3)
Physical activity variables at baseline,^c mean (SD)
Step count (steps per day)	7030.0 (3718.3)
Duration of activity of at least moderate intensity^d (min/day)	92.3 (70.8)
Physical activity level^e	1.514 (0.216)
Daily active energy expenditure >3 metabolic equivalents (kcal/day)	451.1 (372.6)

^aGOLD Stage 2 (moderate): FEV₁/FVC <0.70, and post-bronchodilator FEV₁ ≥50% and <80% predicted; GOLD Stage 3 (severe): FEV₁/FVC <0.70, and post-bronchodilator FEV₁ ≥30% and <50% predicted.
^bPre-dose at Visit 1.
^cMean data for 7-day period prior to Visit 1 (patients who had ≥5 days with ≥22 h of valid data; n = 92).
^dAny physical activity >3 metabolic equivalents.
^eRatio calculated as the total daily energy expenditure divided by the whole of the night sleeping energy expenditure.
COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 s; FRC, functional residual capacity; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; IC, inspiratory capacity; RV, residual volume; SD, standard deviation; sGaw, specific airway conductance; TLC, total lung capacity.

ISSN: 1471-2466