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Table 1 Patient baseline demographic and asthma characteristics, Full Analysis Set

From: Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial

Characteristic

Treatment group

 

Fluticasone/formoterol 100/10 μg b.i.d. N = 115

Fluticasone 100 μg b.i.d. N = 117

Formoterol 10 μg b.i.d. N = 116

Placebo b.i.d. N = 111

Overall N = 459

Gender, n (%)

     

 Female

72 (62.6)

71 (60.7)

63 (54.3)

70 (63.1)

276 (60.1)

 Male

43 (37.4)

46 (39.3)

53 (45.7)

41 (36.9)

183 (39.9)

Ethnic origin, n (%)

 White/Caucasian

89 (77.4)

88 (75.2)

83 (71.6)

79 (71.2)

339 (73.9)

 Black

13 (11.3)

16 (13.7)

21 (18.1)

22 (19.8)

72 (15.7)

 Asian

6 (5.2)

4 (3.4)

5 (4.3)

4 (3.6)

19 (4.1)

 Hispanic

6 (5.2)

8 (6.8)

6 (5.2)

5 (4.5)

25 (5.4)

 Other

1 (0.9)

1 (0.9)

1 (0.9)

1 (0.9)

4 (0.9)

Age, years

     

 Mean (SD)

39.8 (14.54)

38.3 (14.45)

39.1 (15.26)

38.1 (13.67)

38.8 (14.47)

Age categories, n (%)

 12 to 17 years

7 (6.1)

9 (7.7)

9 (7.8)

6 (5.4)

31 (6.8)

 ≥ 18 years

108 (93.9)

108 (92.3)

107 (92.2)

105 (94.6)

428 (93.2)

Steroid use, n (%)

     

 Freea

59 (51.3)

60 (51.3)

58 (50.0)

55 (49.5)

232 (50.5)

 Requiringb

56 (48.7)

57 (48.7)

58 (50.0)

56 (50.5)

227 (49.5)

Prior ICS and ICS/LABA use, n (%)

 ICS only

31 (27.0)

39 (33.3)

30 (25.9)

35 (31.5)

135 (29.4)

 ICS and LABA

25 (21.7)

18 (15.4)

28 (24.1)

21 (18.9)

92 (20.0)

Duration of asthma, years c

 Mean (SD)

18.9 (13.40)

20.6 (13.84)

20.3 (14.48)

21.4 (12.83)

20.3 (13.64)

FEV 1 % predictedd at baselinee

 Mean (SD)

73.2 (7.54)

73.5 (8.14)

73.2 (7.79)

72.0 (7.97)

73.0 (7.86)

 Median

72.0

75.0

73.0

72.0

73.0

FEV1 at baselinee, L

 Mean (SD)

2.416 (0.5790)

2.425 (0.6625)

2.459 (0.6231)

2.352 (0.6114)

2.414 (0.6192)

 Median

2.370

2.330

2.375

2.250

2.340

Reversibility at screening, %

 

n = 114

n = 117

n = 116

n = 111

n = 458

 Mean (SD)

23.2 (10.1)

22.8 (9.0)

21.8 (8.4)

22.8 (8.3)

22.6 (9.0)

 Median

19.3

19.5

18.7

20.0

19.2

  1. N = total number of patients; n = number of patients in specified category; SD = standard deviation; b.i.d. = twice daily; ICS = inhaled corticosteroids; LABA = long acting beta agonist; FEV1 = Forced Expiratory Volume in the first second.
  2. a. Patient with no history of steroid use for at least 12 weeks prior to the screening visit.
  3. b. Patient who used an inhaled steroid regimen at a dose not greater than 500 μg/day fluticasone (or equivalent steroid) for at least 4 weeks prior to screening.
  4. c. Duration of asthma calculated as (Date of screening visit from Demographics CRF - Asthma diagnosis date)/ 365.25 and rounded to 1 decimal place.
  5. d. Based on standardised predicted FEV1 values.
  6. e. Baseline was the last available value prior to dosing at the baseline/week 0 visit.