Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies

Table 2 Frequency and Intensity of TEAEs Overall and TEAEs Occurring in ≥2 Volunteers in Any Treatment Group in Either Study A or B, by MedDRA^a Preferred Term (Safety Population)

	Study A				Study B
	Placebo n = 6	Navafenterol 300 μg n = 6	Navafenterol 600 μg n = 6	Navafenterol 900 μg nn = 6	Placebo n = 6	Navafenterol 300 μg n = 6	Navafenterol 600 μg n = 6	Navafenterol 900 μg n = 6
Any TEAE, n (%)	4 (66.7)	3(50.0)	1 (16.7)	5 (83.3)	3 (50.0)	4 (66.7)	5 (83.3)	5 (83.3)
Mild	4 (66.7)	3 (50.0)	1 (16.7)	5 (83.3)	3 (50.0)	4 (66.7)	4 (66.7)	4 (66.7)
Moderate	0	2 (33.3)	1 (16.7)	0	0	0	1 (16.7)	1 (16.7)
Diarrhea	0	0	0	0	1 (16.7)	2 (33.3)	0	3 (50.0)
Mild	0	0	0	0	1 (16.7)	2 (33.3)	0	3 (50.0)
Vessel puncture site bruise^b	2 (33.3)	0	0	3 (50.0)	0	0	2 (33.3)	0
Mild	2 (33.3)	0	0	3 (50.0)	0	0	2 (33.3)	0
Headache	0	2 (33.3)	1 (16.7)	0	0	0	0	1 (16.7)
Mild	0	1 (16.7)	0	0	0	0	0	1 (16.7)
Moderate	0	1 (16.7)	1 (16.7)	0	0	0	0	0
Dermatitis contact	0	0	0	1 (16.7)	0	0	2 (33.3)	0
Mild	0	0	0	1 (16.7)	0	0	2 (33.3)	0
Rash	0	0	0	0	1 (16.7)	0	0	2 (33.3)
Mild	0	0	0	0	1 (16.7)	0	0	2 (33.3)
Nasopharyngitis	0	0	0	2 (33.3)	0	0	0	0
Mild	0	0	0	2 (33.3)	0	0	0	0
Oropharyngeal pain	2 (33.3)	0	0	0	0	0	0	0
Mild	2 (33.3)	0	0	0	0	0	0	0

^aMedDRA version 19.0
^b‘Catheter site bruise’ in study B
MedDRA Medical Dictionary for Regulatory Activities, n number of patients, TEAE treatment emergent adverse event

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