TABLE 1

Patient Characteristics (Randomly Assigned Population)

CharacteristicCIC40 (n = 221)aCIC160 (n = 219)aPlacebo (n = 221)a
Characteristics at screening
    Age, y
        Mean (SD)6.6 (0.97)6.7 (0.93)6.7 (0.95)
        Range5.0–8.55.0–8.6b5.0–8.5
    Gender, n (%)
        Male150 (67.9)147 (67.1)147 (66.5)
        Female71 (32.1)72 (32.9)74 (33.5)
    Race, n (%)
        White152 (68.8)163 (74.4)154 (69.7)
        Black9 (4.1)9 (4.1)10 (4.5)
        Asian2 (0.9)2 (0.9)4 (1.8)
        Multiracial12 (5.4)5 (2.3)8 (3.6)
        Other46 (20.8)40 (18.3)45 (20.4)
    Hispanic origin, n (%)133 (60.2)137 (62.6)127 (57.5)
    Stadiometer height, mean (SD), cm119.28 (7.16)119.65 (6.93)120.05 (7.47)
    Weight, mean (SD), kg24.64 (5.20)24.79 (5.62)24.85 (5.71)
    BMI, mean (SD), kg/m217.18 (2.39)17.15 (2.54)17.08 (2.62)
    Duration of asthma, mean (SD), y3.79 (1.95)3.96 (1.98)3.81 (2.04)
    FEV1, mean (SD), L1.33 (0.27)1.34 (0.27)1.35 (0.27)
    FEV1, mean (SD), % predicted96.42 (12.29)96.07 (11.26)95.98 (11.39)
    Medication use ≤30 d before screening, %
        ICSc19.521.019.0
        Leukotriene receptor antagonist52.047.952.0
        Short-acting β1-agonist95.093.696.4
Characteristics at randomization
    Age, y
        Mean (SD)7.1 (0.97)7.2 (0.93)7.2 (0.95)
        Range5.5–9.15.5–9.05.5–9.0
    Age-gender classification, n (%)d
        Male, ≤8 y108 (48.9)106 (48.4)101 (45.7)
        Male, >8 y42 (19.0)41 (18.7)46 (20.8)
        Female, ≤7 y46 (20.8)48 (21.9)43 (19.5)
        Female, >7 y25 (11.3)24 (11.0)31 (14.0)
    Growth velocity, mean (SD), cm/ye6.59 (1.32)6.20 (1.56)6.49 (1.46)
    Stadiometer height, mean (SD), cm122.63 (7.14)122.86 (6.88)123.37 (7.56)
  • a The prespecified sample-size estimate of ≥135 patients per group was exceeded to accommodate potentially high discontinuation rates.

  • b One patient was aged 8.6 years at screening; this patient did not progress past Tanner stage 1 during the entire study.

  • c Includes patients who were receiving an ICS either as monotherapy or in combination with a short-acting or long-acting β2-agonist.

  • d The randomization schedule was stratified according to age-gender classification at randomization.

  • e Linear regression estimate of growth velocity during the 6-month run-in period (mITT population).