Table 3.

Summary of data on 24-hour urinary cortisol excretion in the urine cortisol population^* in a randomized, double-blind, placebo-controlled, two-week study (GlaxoSmithKline FFR20001)²³

	Fluticasone furoate				Placebo
	50 μg	100 μg	200 μg	400 μg
Baseline
n	116	118	121	120	117
Mean, μg /24 hours (SD)	21.9 (18.0)	21.3 (21.8)	22.4 (15.5)	20.4 (12.4)	20.0 (14.3)
Outside normal range, n (%)
>Normal	13 (11)	15 (13)	12 (10)	8 (7)	8 (7)
<Normal	0 (0)	5 (4)	0 (0)	0 (0)	1 (1)
End of the treatment period
n	116	118	122	120	117
Mean, μg /24 hours (SD)	23.9 (23.1)	20.8 (18.3)	21.3 (16.4)	20.9 (14.9)	20.9 (18.7)
Mean change from baseline (SD)	2.0 (26.3)	−0.5 (25.2)	(1.2† (19.5)	0.6 (17.8)	0.9 (20.0)
Outside normal range, n (%)
>Normal	15 (13)	9 (8)	16 (13)	9 (8)	11 (9)
<Normal	1 (1)	2 (2)	1 (1)	1 (1)	1 (1)
Shifts from baseline, n (%)
To low	1 (1)	2 (2)	1 (1)	1 (1)	1 (1)
Remained normal or shifted to normal	104 (90)	111 (94)	108 (89)	112 (93)	107 (91)
To high	11 (9)	5 (4)	13 (11)	7 (6)	9 (8)

Note:

^†n = 121.

^*The urine cortisol population excluded any patients in the intent-to-treat population who had urine volumes of <600 mL for females or <800 mL for males and 24-hour creatinine excretion below the lower limit of the threshold range (defined as mean minus 2.5 SD, where the normal range was defined as the mean ± 2 SD); had a collection time interval outside the range of 24 ± 4 hours; used protocol-prohibited systemic or inhaled corticosteroids within eight weeks or protocol-prohibited intranasal or topical corticosteroids within four weeks before any start time of urine collection; and, for the end-of-study urinary cortisol measure, had not taken study medication for more than one day at the start time of urine collection.

Abbreviation: SD, standard deviation.