A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

Green, Francis H. Y.; Leigh, Richard; Fadayomi, Morenike; Lalli, Gurkeet; Chiu, Andrea; Shrestha, Grishma; ElShahat, Sharif G.; Nelson, David Evan; El Mays, Tamer Y.; Pieron, Cora A.; Dennis, John H.

doi:10.1186/s13063-016-1489-8

Trials

Table 4 Incidence of adverse events by system organ class and preferred terms

From: A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

System organ class	Preferred term	S-1226 (4 % CO₂) (n = 9)	S-1226 (8 % CO₂) (n = 9)	S-1226 (12 % CO₂) (n = 9)	Placebo (n = 9)	Total (n = 36)
Subjects with one or more adverse events		3 (33.3 %)	1 (11.1 %)	9 (100 %)	3 (33.3 %)	16 (44.4 %)
Subjects with no adverse events		6 (66.7 %)	8 (88.9 %)	0 (0 %)	6 (66.7 %)	20 (55.6 %)
Cardiac disorders	Bradycardia	1 (11.1 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	2 (5.6 %)
	Palpitations	0 (0 %)	0 (0 %)	0 (0 %)	1 (11.1 %)	1 (2.8 %)
	Hypertension	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
	Subtotal	1 (11.1 %)	0 (0 %)	2 (22.2 %)	1 (11.1 %)	4 (11.1 %)
General disorders and administration site conditions	Feeling hot	0 (0 %)	0 (0 %)	3 (33.3 %)	0 (0 %)	3 (8.3 %)
General disorders and administration site conditions	Subtotal	0 (0 %)	0 (0 %)	3 (33.3 %)	0 (0 %)	3 (8.3 %)
Investigations	Neutrophil count decreased	0 (0 %)	0 (0 %)	2 (22.2 %)	1 (11.1 %)	3 (8.3 %)
	White blood cell count decreased	0 (0 %)	0 (0 %)	0 (0 %)	1 (11.1 %)	1 (2.8 %)
	Electrocardiogram QT prolongation	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
	Electrocardiogram PR prolongation	0 (0 %)	0 (0 %)	0 (0 %)	1 (11.1 %)	1 (2.8 %)
	Subtotal	0 (0 %)	0 (0 %)	3 (33.3 %)	3 (33.3 %)	6 (16.7 %)
Nervous system disorders	Dizziness	0 (0 %)	0 (0 %)	3 (33.3 %)	0 (0 %)	3 (8.3 %)
	Headache	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
	Somnolence	2 (22.2 %)	1 (11.1 %)	1 (11.1 %)	0 (0 %)	4 (11.1 %)
	Subtotal	2 (22.2 %)	1 (11.1 %)	5 (55.6 %)	0 (0 %)	8 (22.2 %)
Respiratory, thoracic, and mediastinal disorders	Cough	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
	Dyspnea	0 (0 %)	0 (0 %)	3 (33.3 %)	0 (0 %)	3 (8.3 %)
	Respiratory tract irritation	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
	Throat irritation	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
	Subtotal	0 (0 %)	0 (0 %)	6 (66.7 %)	0 (0 %)	6 (16.7 %)
Vascular disorders	Tachycardia	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)
Vascular disorders	Subtotal	0 (0 %)	0 (0 %)	1 (11.1 %)	0 (0 %)	1 (2.8 %)

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