Table 1.

Baseline demographics and clinical characteristics

	Placebo [N = 54]	Budesonide foam QD [N = 55]	Budesonide foam BID [N = 56]	Total [N = 165]
Age [years], mean [SD]	39.9 [13.0]	44.7 [13.3]	40.8 [11.2]	41.8 [12.6]
Male sex, n [%]	31 [57.4]	32 [58.2]	26 [46.4]	89 [53.9]
Body weight [kg], mean [SD]	61.7 [10.3]	60.7 [13.7]	60.1 [11.5]	60.8 [11.9]
Current smoker, n [%]	3 [5.6]	1 [1.8]	5 [8.9]	9 [5.5]
Duration of disease [years], mean [SD]	3.5 [3.5]	5.7 [5.6]	5.8 [5.9]	5.0 [5.2]
Clinical course, n [%]
First attack	8 [14.8]	6 [10.9]	9 [16.1]	23 [13.9]
Relapsing/remitting	46 [85.2]	49 [89.1]	47 [83.9]	142 [86.1]
Duration of present active phase [days], mean [SD]	108.9 [202.4]	86.0 [131.3]	95.3 [140.4]	96.6 [160.0]
<4 weeks, n [%]	22 [40.7]	27 [49.1]	27 [48.2]	76 [46.1]
≥4 weeks, n [%]	32 [59.3]	28 [50.9]	29 [51.8]	89 [53.9]
Extent of lesions, n [%]
Proctitis	25 [46.3]	26 [47.3]	28 [50.0]	79 [47.9]
Sigmoiditis	29 [53.7]	29 [52.7]	28 [50.0]	86 [52.1]
MMDAI, n [%]
Score 3–5	27 [50.0]	26 [47.3]	25 [44.6]	78 [47.3]
Score 6–8	27 [50.0]	29 [52.7]	31 [55.4]	87 [52.7]
Previous medication for UC — n [%]
Oral 5-ASA	47[87.0]	48[87.3]	44[78.6]	139[84.2]
5-ASA enema or suppository	21[38.9]	23[41.8]	25[44.6]	69[41.8]
Concomitant therapy for UC— n [%]
Oral 5-ASA	47 [87.0]	48 [87.3]	43 [76.8]	138 [83.6]
Oral salazosulfapyridine	0 [0.0]	0 [0.0]	1 [1.8]	1 [0.6]
None	7 [13.0]	7 [12.7]	12 [21.4]	26 [15.8]

MMDAI, Modified Mayo Disease Activity Index; BID, twice a day administration; QD, once daily administration; SD, standard deviation, 5-ASA, 5-aminosalicylic acid; UC, ulcerative colitis.