Asthma control in pediatric patients treated with once-daily or twice-daily nebulized budesonide inhalation suspension (Pulmicort Respules).

Composite end points may represent more meaningful assessments of asthma control compared with traditional discrete measures. The effects of budesonide inhalation suspension (BIS) on composite measures of asthma control have not been investigated. The purpose of this study was to assess changes from baseline in percentages of asthma control days (ACDs; days without asthma symptoms and rescue medication use; primary outcome), symptom-free days (SFDs), and rescue medication-free days (RFDs) with BIS treatment. We retrospectively analyzed separately data from three randomized, double-blind, placebo-controlled, 12-week studies (N = 1018) of BIS. Study I patients (4-8 years) were dependent on daily inhaled corticosteroids (ICS; n = 178). Study II patients (6 months to 8 years) were using one or more asthma medications (n = 481). Study III patients (6 months to 8 years) were using daily non-ICS asthma medication (n = 359). Patients treated with BIS showed substantial improvements from baseline in all composite variables (ACDs, 21-31% versus placebo [PBO], 10-18%; SFDs, 20-29% versus PBO, 11-18%; RFDs, 24-47% versus PBO, 12-28%). In study I, each BIS regimen statistically significantly improved all three asthma control measures versus PBO. In study II, BIS 0.5 mg twice daily (b.i.d.) improved ACDs, BIS 0.25 mg b.i.d. and 0.5 mg b.i.d. improved SFDs, and all BIS regimens improved RFDs statistically significantly. In study III, BIS 0.25 mg once daily (q.d.) improved all three measures, BIS 0.5 mg q.d. improved SFDs, and 1.0 mg q.d. improved RFDs statistically significantly. In conclusion, BIS improved composite measures of asthma control in children.