A randomized, three-period crossover study of umeclidinium as monotherapy in adult patients with asthma
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Keywords
Asthma
Fixed-dose combination
Muscarinic antagonist
Inhaled corticosteroid
Trough FEV1
Abbreviations
Ae
amount of dose excreted unchanged in urine
AE
adverse event
ALT
alanine aminotransferase
AUC
area under the curve
BID
twice daily
bpm
beats per minute
CI
confidence interval
Cmax
maximum plasma concentration
COPD
chronic obstructive pulmonary disease
ECG
electrocardiogram
Fe
percentage of total dose excreted in urine
FEV1
forced expiratory volume in one second
GCP
Good Clinical Practice
HLQ
higher limit of quantification
ICS
inhaled corticosteroid
ICH
International Conference on Harmonisation
INR
international normalized ratio
LAMA
long-acting muscarinic antagonist
LLQ
lower limit of quantification
LS
least squares
NA
not available
NC
non-calculable
ND
not determined
NQ
non-quantifiable
OD
once daily
PEF
peak expiratory flow
PK
pharmacokinetic
PVC
premature ventricular contraction
SAE
serious adverse event
SD
standard deviation
SE
standard error
Tlast
time of the last point with quantifiable concentration
Tmax
time to maximum plasma concentration
ULN
upper limit of normal
UMEC
umeclidinium bromide
VPD
ventricular premature depolarization
WM
weighted mean
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Copyright © 2014 The Authors. Published by Elsevier Ltd.