Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma

L. P. Boulet, A. Drollmann, P. Magyar, M. Timar, A. Knight, R. Engelstätter, L. Fabbri

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Background: The aim of this study was to compare the efficacy and safety of once-daily ciclesonide, a new-generation, on-site-activated, inhaled corticosteroid, with once-daily budesonide in persistent asthma. Methods: Eligible patients requiring budesonide or equivalent 320-640 μg (ex-mouthpiece, equivalent to 400-800 μg; Turbohaler™) daily entered a 2-week baseline, and then a 2- to 4-week pretreatment period (budesonide 1280 μg/day; ex-mouthpiece, equivalent to 1600 μg/day). Patients with an increase in forced expiratory volume in 1 s (FEV1) of {greater than or slanted equal to}7% or {greater than or slanted equal to}0.15 L were randomised to ciclesonide 320 μg (ex-actuator, equivalent to 400 μg ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 μg once daily in the morning for 12 weeks. Change in FEV1 was the primary endpoint. Results: In all, 359 patients were randomised. The FEV1 and forced vital capacity (FVC) decreased by 0.18 and 0.12 L, respectively, in the ciclesonide group, and by 0.23 and 0.21 L in the budesonide group. For FEV1, ciclesonide was noninferior and numerically superior to budesonide. For FVC, ciclesonide was statistically superior to budesonide (P=0.010). Asthma symptom scores were comparable; the median percentage of symptom-free days was significantly higher for ciclesonide (43.6%) versus budesonide (25.8%) (P=0.017). Rescue medication use decreased significantly only for ciclesonide patients (P=0.009). Frequency of adverse events was low in both groups. Conclusion: Ciclesonide 320 μg once daily by HFA-MDI without a spacer was at least as effective as budesonide 320 μg once daily in persistent asthma.

Original languageEnglish
Pages (from-to)785-794
Number of pages10
JournalRespiratory Medicine
Volume100
Issue number5
DOIs
Publication statusPublished - May 2006

Fingerprint

Budesonide
Asthma
HFA 134a
Forced Expiratory Volume
Metered Dose Inhalers
Therapeutics
Vital Capacity
ciclesonide
Adrenal Cortex Hormones
Safety

Keywords

  • Asthma
  • Budesonide
  • Ciclesonide
  • Inhaled corticosteroids
  • Once daily

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma. / Boulet, L. P.; Drollmann, A.; Magyar, P.; Timar, M.; Knight, A.; Engelstätter, R.; Fabbri, L.

In: Respiratory Medicine, Vol. 100, No. 5, 05.2006, p. 785-794.

Research output: Contribution to journalArticle

Boulet, LP, Drollmann, A, Magyar, P, Timar, M, Knight, A, Engelstätter, R & Fabbri, L 2006, 'Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma', Respiratory Medicine, vol. 100, no. 5, pp. 785-794. https://doi.org/10.1016/j.rmed.2005.11.030
Boulet, L. P. ; Drollmann, A. ; Magyar, P. ; Timar, M. ; Knight, A. ; Engelstätter, R. ; Fabbri, L. / Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma. In: Respiratory Medicine. 2006 ; Vol. 100, No. 5. pp. 785-794.
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abstract = "Background: The aim of this study was to compare the efficacy and safety of once-daily ciclesonide, a new-generation, on-site-activated, inhaled corticosteroid, with once-daily budesonide in persistent asthma. Methods: Eligible patients requiring budesonide or equivalent 320-640 μg (ex-mouthpiece, equivalent to 400-800 μg; Turbohaler™) daily entered a 2-week baseline, and then a 2- to 4-week pretreatment period (budesonide 1280 μg/day; ex-mouthpiece, equivalent to 1600 μg/day). Patients with an increase in forced expiratory volume in 1 s (FEV1) of {greater than or slanted equal to}7{\%} or {greater than or slanted equal to}0.15 L were randomised to ciclesonide 320 μg (ex-actuator, equivalent to 400 μg ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 μg once daily in the morning for 12 weeks. Change in FEV1 was the primary endpoint. Results: In all, 359 patients were randomised. The FEV1 and forced vital capacity (FVC) decreased by 0.18 and 0.12 L, respectively, in the ciclesonide group, and by 0.23 and 0.21 L in the budesonide group. For FEV1, ciclesonide was noninferior and numerically superior to budesonide. For FVC, ciclesonide was statistically superior to budesonide (P=0.010). Asthma symptom scores were comparable; the median percentage of symptom-free days was significantly higher for ciclesonide (43.6{\%}) versus budesonide (25.8{\%}) (P=0.017). Rescue medication use decreased significantly only for ciclesonide patients (P=0.009). Frequency of adverse events was low in both groups. Conclusion: Ciclesonide 320 μg once daily by HFA-MDI without a spacer was at least as effective as budesonide 320 μg once daily in persistent asthma.",
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AU - Timar, M.

AU - Knight, A.

AU - Engelstätter, R.

AU - Fabbri, L.

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N2 - Background: The aim of this study was to compare the efficacy and safety of once-daily ciclesonide, a new-generation, on-site-activated, inhaled corticosteroid, with once-daily budesonide in persistent asthma. Methods: Eligible patients requiring budesonide or equivalent 320-640 μg (ex-mouthpiece, equivalent to 400-800 μg; Turbohaler™) daily entered a 2-week baseline, and then a 2- to 4-week pretreatment period (budesonide 1280 μg/day; ex-mouthpiece, equivalent to 1600 μg/day). Patients with an increase in forced expiratory volume in 1 s (FEV1) of {greater than or slanted equal to}7% or {greater than or slanted equal to}0.15 L were randomised to ciclesonide 320 μg (ex-actuator, equivalent to 400 μg ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 μg once daily in the morning for 12 weeks. Change in FEV1 was the primary endpoint. Results: In all, 359 patients were randomised. The FEV1 and forced vital capacity (FVC) decreased by 0.18 and 0.12 L, respectively, in the ciclesonide group, and by 0.23 and 0.21 L in the budesonide group. For FEV1, ciclesonide was noninferior and numerically superior to budesonide. For FVC, ciclesonide was statistically superior to budesonide (P=0.010). Asthma symptom scores were comparable; the median percentage of symptom-free days was significantly higher for ciclesonide (43.6%) versus budesonide (25.8%) (P=0.017). Rescue medication use decreased significantly only for ciclesonide patients (P=0.009). Frequency of adverse events was low in both groups. Conclusion: Ciclesonide 320 μg once daily by HFA-MDI without a spacer was at least as effective as budesonide 320 μg once daily in persistent asthma.

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