Randomized comparison of the efficacy and safety of ciclesonide and budesonide in adolescents with severe asthma

J. H. Vermeulen, K. Gyurkovits, H. Rauer, R. Engelstätter

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Background: The aim of the study was to investigate the efficacy and safety of ciclesonide compared with budesonide in adolescents with severe asthma. Methods: In this randomized, double-blind, double-dummy, parallel-group study, patients aged 12-17 years with severe asthma were treated with budesonide 400 μg once daily (QD) in a 2-week run-in period. At randomization, eligible patients were assigned 2:1 to ciclesonide 320 μg QD (ex-actuator) or budesonide 800 μg QD (metered dose), respectively, in the evening. Forced expiratory volume in 1 s (FEV1) was the primary variable. Patients recorded asthma symptom score and rescue medication use in diaries. Safety assessments included adverse events (AEs) and 24-h urine cortisol. Results: Four hundred and three patients were randomized. Ciclesonide 320 μg QD and budesonide 800 μg QD significantly increased FEV1 (least-squares mean: 505 and 536 mL, respectively; both p

Original languageEnglish
Pages (from-to)2182-2191
Number of pages10
JournalRespiratory Medicine
Volume101
Issue number10
DOIs
Publication statusPublished - Oct 2007

Fingerprint

Budesonide
Asthma
Safety
Forced Expiratory Volume
Random Allocation
Least-Squares Analysis
Hydrocortisone
Urine
ciclesonide

Keywords

  • Adolescent
  • Asthma
  • Budesonide
  • Ciclesonide
  • Cortisol

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Randomized comparison of the efficacy and safety of ciclesonide and budesonide in adolescents with severe asthma. / Vermeulen, J. H.; Gyurkovits, K.; Rauer, H.; Engelstätter, R.

In: Respiratory Medicine, Vol. 101, No. 10, 10.2007, p. 2182-2191.

Research output: Contribution to journalArticle

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