Table 2.

Changes From Baseline to Double-blind Treatment in Efficacy Variables

PlaceboBudesonide Nebulizing Suspension
0.25 mg
QD
0.25 mg
BID
0.5 mg
BID
1.0 mg
QD
Daytime asthma
symptom score
−0.19 (n = 92)−0.28 (n = 92)−0.40* (n = 97)−0.46** (n = 96)−0.37* (n = 93)
Nighttime asthma
symptom score
−0.13 (n = 92)−0.28 (n = 93)−0.493-165 (n = 97)−0.42** (n = 96)−0.40** (n = 93)
Morning PEF (L/min)−0.2 (n = 32)10.9 (n = 32)23.0** (n = 34)24.8** (n = 29)17.1* (n = 34)
Evening PEF (L/min)1.9 (n = 32)16.8* (n =32)19.2* (n = 34)21.0** (n = 29)14.1 (n = 34)
FEV1(L/min)0.04 (n = 28)0.07 (n = 31)0.08 (n = 33)0.17* (n = 29)0.11 (n = 34)
  • * P ≤ .050,

  • ** P ≤ .010, and

  • F3-165 P≤ .001, versus placebo.

  • Data expressed as the adjusted mean change from baseline over the 12-week treatment phase, all patients treated, last value carried forward.