Table 3. Clinical studies with once-daily budesonide inhalation suspension for nebulization

Study (No. patients)		Study design		Drugs/dosages		Age; severity of persistent asthma		Efficacy variables: statistically significant results		Safety results
Kemp et al, 1999 (n=359)		DB, R, PG 12 weeks		BUD 0.25, 0.5, 1.0 mg qd or Pl via Pari LC-Jet Plus nebulizer		Children (6 months-8 years) Mild asthma not maintained on ICS		Reductions in asthma symptom scores: All BUD > Pl Reduction in ß2 agonist use: all BUD groups Change in FEV1: BUD 0.5 and 1.0 mg groups > Pl		Non-asthma related AE profiles similar between groups SAE: none Discontinuations: bronchospasm (1 in 0.25 mg and 1 in 0.5 mg group), meningitis (1 in 0.25 mg group), cellulitis (1 in 0.5 mg group) Basal a.m. cortisol and ACTH test: All BUD = Pl
Baker et al, 1999 (n=480)		DB, R, PG 12 weeks		BUD 0.25 or 1.0 mg morning qd, BUD 0.25, 0.5 mg bid or Pl via Pari LC- Jet Plus nebulizer		Children Moderate asthma (70% of population). Previous treatment with ICS discontinued (30% of population)		Reduction in asthma symptoms: by week 2, all BUD groups > Pl PEF, FEV1 and asthma symptoms: 0.5 mg bid and 1.0 mg qd > Pl; 0.5 mg bid > 1.0 mg qd Evening PEF: 0.25 mg qd > Pl		SAE: 4 in 0.25 mg qd, 4 in 1.0 mg qd, 4 in Pl, 2 and 1 in the bid groups AE: profiles similar in all groups Basal a.m. cortisol and ACTH test: profiles similar in all groups

Abbreviations used: AE = adverse event; bid = twice daily; BUD = budesonide; DB = double-blind; FEV1 = forced expiratory volume in one second; PC20 methacholine = the reduction in the provocative dose of methacholine causing a 20% decrease in FEV1; FVC = forced vital capacity; PEF = peak expiratory flow; PG = parallel group; Pl = placebo; qd = once daily; R = randomized; SAE = serious adverse event; Print Page