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Table 1 Summary of baseline characteristics and demographic data (ITT population)

From: A randomized, double-blinded, double-dummy efficacy and safety study of budesonide–formoterol Spiromax® compared to budesonide–formoterol Turbuhaler® in adults and adolescents with persistent asthma

 

BF Spiromax (n = 303)

BF Turbuhaler (n = 302)

Age, years (mean ± SD)

48.1 ± 16.24

46.9 ± 16.89

Sex, n (%)

 Male

131 (43)

141 (47)

 Female

172 (57)

161 (53)

Race, n (%)

 White

297 (98)

300 (>99)

 Black

2 (<1)

1 (<1)

 Asian

1 (<1)

1 (<1)

 Other

3 (<1)

0 (0)

Weight, Kg (mean ± SD)

77.4 ± 17.25

78.6 ± 17.88

Median weekly averaged AM PEF, L/min (range)

318.6 (82.9–632.9)

345.7 (108.6–604.3)

Median weekly averaged PM PEF, L/min (range) (L/min)

328.6 (98.6–650.0)

352.9 (127.1–635.7)

Median baseline FEV1, L (range) (L)

2.1 (0.9–4.2)

2.3 (0.8–4.0)

Prior asthma medications, ≥5 % (n [%])

 Salbutamol

290 (96)

281 (93)

 Budesonide

145 (48)

139 (46)

 Fluticasone

77 (25)

73 (24)

 Budesonide–formoterol

48 (16)

43 (14)

 Fluticasone and salmeterol

43 (14)

37 (12)

Average symptom-free 24-hour period, % (mean ± SD)

19 ± 31.67a

15.3 ± 26.4b

Average rescue-free 24-hour period, % (mean ± SD)

33.3 ± 38.26a

30.9 ± 37.02b

  1. AM ante meridiem (morning), BF budesonide–formoterol, FEV 1 forced expiratory volume in 1 s, ITT intent-to-treat, PEF peak expiratory flow, PM post meridiem (evening), SD standard deviation
  2. a n = 290 (per-protocol population)
  3. b n = 284 (per-protocol population)