Comparison of the efficacy and safety of ciclesonide 160 μg once daily vs. budesonide 400 μg once daily in children with asthma

Abstract

Ciclesonide is an onsite-activated inhaled corticosteroid (ICS) for the treatment of asthma. This study compared the efficacy, safety and effect on quality of life (QOL) of ciclesonide 160 microg (ex-actuator; nominal dose 200 microg) vs. budesonide 400 microg (nominal dose) in children with asthma. Six hundred and twenty-one children (aged 6-11 yr) with asthma were randomized to receive ciclesonide 160 microg (ex-actuator) once daily (via hydrofluoroalkane metered-dose inhaler and AeroChamber Plus spacer) or budesonide 400 microg once daily (via Turbohaler) both given in the evening for 12 wk. The primary efficacy end-point was change in forced expiratory volume in 1 s (FEV1). Additional measurements included change in daily peak expiratory flow (PEF), change in asthma symptom score sum, change in use of rescue medication, paediatric and caregiver asthma QOL questionnaire [PAQLQ(S) and PACQLQ, respectively] scores, change in body height assessed by stadiometry, change in 24-h urinary cortisol adjusted for creatinine and adverse events. Both ciclesonide and budesonide increased FEV1, morning PEF and PAQLQ(S) and PACQLQ scores, and improved asthma symptom score sums and the need for rescue medication after 12 wk vs. baseline. The non-inferiority of ciclesonide vs. budesonide was demonstrated for the change in FEV1 (95% confidence interval: -75, 10 ml, p = 0.0009, one-sided non-inferiority, per-protocol). In addition, ciclesonide and budesonide showed similar efficacy in improving asthma symptoms, morning PEF, use of rescue medication and QOL. Ciclesonide was superior to budesonide with regard to increases in body height (p = 0.003, two-sided). The effect on the hypothalamic-pituitary-adrenal axis was significantly different in favor of ciclesonide treatment (p < 0.001, one-sided). Both ciclesonide and budesonide were well tolerated. Ciclesonide 160 microg once daily and budesonide 400 microg once daily were effective in children with asthma. In addition, in children treated with ciclesonide there was significantly less reduction in body height and suppression of 24-h urinary cortisol excretion compared with children treated with budesonide after 12 wk.

Similar Results in Children with Asthma for Steady State Pharmacokinetic Parameters of Ciclesonide Inhaled with or without Spacer

“…A few patients reported adverse events that were mild or moderate in intensity; all events resolved completely and all were assessed by the investigator as ‘not related’ to ciclesonide. The safety results are consistent with those of other clinical studies with ciclesonide which confirmed good overall safety profile in adults and children treated for asthma 7,16–20…”

“…Ciclesonide, is a new ICS delivered via HFA-MDI, which has been shown to be effective and safe in clinical studies with adults and children 7,12,13,15–20,28. The study presented here is part of a drug characterization program for ciclesonide to evaluate the effect of a spacer (AeroChamber Plus™) on the PK parameters in children with asthma (6 to 11 years old).…”

“…These properties ensure high local anti-inflammatory activity of des-CIC in the lung associated with low systemic activity 7–11. The efficacy and safety of ciclesonide with the dose 80 μg/day or 160 μg/day in treatment of asthma has been demonstrated in several studies with adults,7,12–14 adolescent,15 and children 16–20…”

Risk of pneumonia in obstructive lung disease: A real-life study comparing extra-fine and fine-particle inhaled corticosteroids

“…[3,4,53,54] In mild-to-moderate asthma, ICS dose-dependent improvements in markers of control occur, but the dose-response profile is shallow and use of higher ICS doses does not increase the efficacy of these drugs and comes at an expense of an increase in the incidence of side effects. [54–56] Extra-fine particle ICS have a favourable safety profile with decreased local and systemic exposure, and are associated with improved clinical outcomes when compared to equivalent ICS doses of larger sized aerosols in patients with asthma and COPD,[31–34,39,40]. In these patients extra-fine ICS formulations can perhaps be used at lower doses without compromising on symptom control.…”

“…[30] RCTs comparing the short-term efficacy of efBDP and efCIC to that of fine-particle ICS have found that extra-fine formulations offer equivalent efficacy when administered at half the dose of fine-particle ICS in both asthma and COPD. [31–34] Indeed, a rigorous dose response study has confirmed that efBDP provides significantly greater effects on lung function than comparable doses of fine-particle BDP. Of note, the improvements in obstructive lung disease symptoms and quality of life tend to be better with efBDP than fine-particle BDP at twice the dose,[35–40] suggesting that there may be clinically meaningful differences between the extra-fine particle and fine-particle formulations.…”