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Table 4 Summary of on-treatment AESIs (ITT population)

From: A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids

 Placebo
(N =143)
n (%)
UMEC 31.25 mcg
(N =139)
n (%)
UMEC 62.5 mcg
(N =139)
n (%)
Adrenal suppression000
Anticholinergic syndrome (SMQ)*1 (<1)1 (<1)3 (2)
CV effects*10 (7)7 (5)6 (4)
 Hypertension (SMQ)7 (5)5 (4)4 (3)
 Cardiac arrhythmia1 (<1)1 (<1)1 (<1)
 Ischaemic heart disease (SMQ)1 (<1)01 (<1)
 Cardiac failure (SMQ)1 (<1)1 (<1)0
 CNS haemorrhages and cerebrovascular conditions (SMQ)1 (<1)00
Decreased BMD and associated fractures000
Dry mouth/drying of the airway secretions (broad focus)*28 (20)29 (21)27 (19)
Dry mouth/drying of the airway secretions (narrow focus)*001(<1)
Gastrointestinal obstruction (SMQ)*000
Hyperglycaemia/ new onset diabetes mellitus (SMQ)1 (<1)00
Hypersensitivity*3 (2)3 (2)1 (<1)
Infective pneumonia (SMQ)*1 (<1)1 (<1)0
LRTI (excluding infective pneumonia SMQ)*3 (2)2 (1)6 (4)
Local steroid effects5 (3)12 (9)6 (4)
Ocular effects*01 (<1)0
 Glaucoma (SMQ)01 (<1)0
 Lens disorders (SMQ)000
Urinary retention*1 (<1)00
  1. *Special interest groups related to UMEC and LAMAs
  2. AESI adverse event of special interest, BMD bone mineral density, CNS central nervous system, CV cardiovascular, ITT intent-to-treat, LAMA long-acting muscarinic antagonist, LRTI lower respiratory tract infections, MedDRA Medical Dictionary for Regulatory Activities, SMQ standardised MedDRA queries, UMEC umeclidinium