A crossover randomized comparative study of zofenopril and ramipril on cough reflex and airway inflammation in healthy volunteers

Cough

Table 2 Study assessments and timetable

	1st treatment period							Wash-out	2nd treatment period
Day(s)	1	2	3	4	5	6	7	8-29(±2)	30	31	32	33	34	35	36
Drug dosing	x	x	x	x	x	x	x		x	x	x	x	x	x	x
Vital signs recordings	x						x		x						x
Capsaicin and citric acid challenges	x						x		x						x
Spontaneous cough recordings at home	From day 1 to 7								From day 30 to 36
FeNO measurement^a	x						x		x						x
Assessment of pre-dose PK parameters	x		x		x	x	x		x		x		x	x	x
Assessment of post-dose PK parameters^b							x								x
Pre-dose BK measurements	x						x		x						x
Post-dose BK measurements^c							x								x
AE monitoring	From day 1 to 7									From day 30 to 36

FeNO, fractional exhaled nitric oxide; AE, adverse event; PK, pharmacokinetic; BK, bradykinin; ^a FeNO assessments were performed at pre-dose, 1.5 h and 5.5 h post-dose; ^bBlood samples obtained 20', 40', 1 h, 1 h30', 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 16 h, 24 h after drug administration; ^c measurement performed 40', 1 h, 2 h, 4 h, 6 h, 10 h, 16 h, and 24 h after drug administration.