Abediterol, a novel long-acting β2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD

Table 1 Patient demographics and baseline characteristics (safety population)

Characteristic	Patients (N = 70)	Median	Quartiles
Characteristic	Patients (N = 70)	Median	Q1	Q3
Age (years), mean (SD)	61.2 (7.7)	62.0	56.0	66.0
BMI (kg/m²), mean (SD)	27.35 (4.20)	27.21	24.25	30.12
Gender (male), n (%)	44 (62.86)
Race (Caucasian), n (%)	69 (98.57)
Current smoker, n (%)	41 (58.57)
Smoking history (pack-years), mean (SD)	48.96 (27.98)	41.25	31.00	61.20
Severity of airflow limitation, n (%)
Moderate (GOLD Stage II)	49 (70.0)
Severe (GOLD Stage III)	21 (30.0)
Post-bronchodilator FEV₁ (L)
Mean (SD)	1.72 (0.57)	1.71	1.20	2.04
% predicted, mean (SD)	58.03 (12.57)	57.95	49.20	68.90
Post-bronchodilator FVC (L)
Mean (SD)	3.57 (0.99)	3.52	2.76	4.23
% predicted, mean (SD)	97.64 (16.62)	98.70	86.50	107.80
FEV₁/FVC ratio (%), mean (SD)	48.53 (10.28)	48.10	40.50	56.30
Bronchial reversibility (%), mean (SD)^a	15.74 (13.25)	13.25	6.90	20.20
Prior COPD medication^b, n (%)
SABA	66 (94.29)
LAMA	17 (24.29)
LABA/ICS	17 (24.29)
LABA	16 (22.86)
ICS	8 (11.43)
SABA + SAMA	4 (5.71)
Xanthines	4 (5.71)
SAMA	2 (2.86)
Influenza vaccine	1 (1.43)
Oxygen	1 (1.43)

^aBronchial reversibility was assessed using salbutamol 100 μg per puff and was defined as ≥12 % and ≥200 mL change from pre-test FEV₁.’ BMI body mass index, 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, SABA short-acting β₂-agonist, SAMA short-acting muscarinic antagonist, SD standard deviation
^bPrior medication defined as any medication within 15 days prior to the date of informed consent and up to the first investigational medicinal product administration

ISSN: 1471-2466