Table 2.

Outcomes.^*

Outcomes	Low-Dose Group (N = 127)	High-Dose Group (N = 127)	Treatment Effect (95% CI)†	P Value
Primary outcome
No. of exacerbations per year (95% CI)	0.37 (0.25 to 0.55)	0.48 (0.33 to 0.70)	1.3 (0.8 to 2.1)	0.30
Secondary outcomes
No. of emergency department or urgent care visits per year (95% CI)	0.47 (0.31 to 0.72)	0.64 (0.42 to 0.96)	1.3 (0.8 to 2.4)	0.30
No. of hospitalizations	0	4	—	0.12
Equivalent of hydrocortisone exposure — g/yr (95% CI)
Fluticasone only	10.6 (10.4 to 10.9)	12.2 (11.9 to 12.4)	1.14 (1.10 to 1.19)
Fluticasone and prednisone	11.1 (10.6 to 11.4)	12.8 (12.4 to 13.2)	1.16 (1.10 to 1.22)
Growth — cm/yr (95% CI)
Mean	5.65 (5.48 to 5.81)	5.43 (5.26 to 5.60)	−0.23 (−0.47 to 0.01)	0.06
Effect per 7-day exposure to high-dose regimen
Overall	—	−0.07 (−0.17 to 0.03)	−0.07 (−0.17 to 0.03)	0.20
According to age group‡
5-7 yr	—	−0.12 (−0.22 to −0.02)	−0.12 (−0.22 to −0.02)	0.02
8-11 yr	—	0.02 (−0.21 to 0.26)	0.02 (−0.21 to 0.26)	0.80

^*The primary outcome was the rate of severe asthma exacerbations (number of events per year) treated with systemic glucocorticoids during the blinded treatment period.

^†The treatment effect is a relative rate for the primary outcome of the number of exacerbations per year and for the secondary outcomes of the number of emergency department or urgent care visits per year. The treatment effect is a relative difference for the secondary outcomes related to hydrocortisone exposure equivalents. The treatment effect is an absolute difference (measured in centimeters per year) for the secondary outcomes regarding growth.

^‡A total of 126 participants were 5 to 7 years of age, and 128 were 8 to 11 years of age.