Skip to main content

Table 1 Patient demographics and baseline disease characteristics (Phase 2 trial)

From: Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies

 

Placebo

Setipiprant 100 mg b.i.d.

Setipiprant 500 mg b.i.d.

Setipiprant 1000 mg b.i.d.

Setipiprant 1000 mg o.d.

Cetirizine 10 mg o.d.

Patients, n

96

98

97

96

96

96

Age in years, mean (SD)

42.2 (13.0)

43.0 (12.1)

42.0 (13.9)

41.6 (11.7)

41.8 (12.8)

43.4 (12.8)

Sex (% male: % female)

28: 72

24: 77

32: 68

30: 70

35: 65

30: 70

Ethnicity, n (%):

 Caucasian

62 (65)

56 (57)

56 (58)

58 (60)

47 (49)

51 (53)

 Black

3 (3)

9 (9)

9 (9)

7 (7)

7 (7)

6 (6)

 Hispanic

31 (32)

30 (31)

32 (33)

31 (32)

41 (43)

39 (41)

 Other

–

3 (3)

–

–

1 (1)

–

AR duration in years, mean (SD)

18.8 (12.2)

19.3 (11.4)

19.1 (11.5)

18.9 (12.3)

19.8 (12.3)

21.7 (16.8)

Baseline DNSS, mean (SD)a

2.25 (0.42)

2.25 (0.40)

2.26 (0.43)

2.26 (0.41)

2.24 (0.41)

2.24 (0.42)

  1. All-randomised set
  2. AR allergic rhinitis, DNSS daytime nasal symptom score, SD standard deviation
  3. aModified all-treated set