Maintenance of asthma control by once‐daily inhaled ciclesonide in adults with persistent asthma

Background:  Inhaled corticosteroids (ICS) are recommended therapy for persistent asthma, although side effects can limit appropriate use. Ciclesonide, a novel ICS, is activated in the lung, thereby reducing systemic activity and side effects. This 12‐week, double‐blind, randomized, parallel‐group,...

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Bibliographic Details
Published in:Allergy (Copenhagen) 2005-03, Vol.60 (3), p.330-337
Main Authors: Chapman, K. R., Patel, P., D'Urzo, A. D., Alexander, M., Mehra, S., Oedekoven, C., Engelstätter, R., Boulet, L.‐P.
Format: Article
Language:English
Subjects:
Administration, Inhalation
Adult
Adults
Aged
Allergic diseases
Anti-Asthmatic Agents - administration & dosage
Anti-Asthmatic Agents - adverse effects
Anti-Asthmatic Agents - therapeutic use
Asthma
Asthma - blood
Asthma - drug therapy
Asthma - physiopathology
Biological and medical sciences
ciclesonide
cortisol
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Humans
Hydrocortisone - blood
Immunopathology
inhaled corticosteroids
Male
Medical sciences
Middle Aged
Peak Expiratory Flow Rate
Pregnenediones - administration & dosage
Pregnenediones - adverse effects
Pregnenediones - therapeutic use
Respiratory therapy
safety
Salvage Therapy
Spirometry
Steroids
Treatment Outcome
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Summary:Background:  Inhaled corticosteroids (ICS) are recommended therapy for persistent asthma, although side effects can limit appropriate use. Ciclesonide, a novel ICS, is activated in the lung, thereby reducing systemic activity and side effects. This 12‐week, double‐blind, randomized, parallel‐group, placebo‐controlled study evaluated the efficacy and safety of ciclesonide in adults with persistent asthma. Methods:  After a 2‐week baseline period in which current ICS treatment was continued, 329 patients were randomized to receive ciclesonide 160 μg (n = 107) or 640 μg (n = 112) (ex‐actuator doses, equivalent to 200 and 800 μg ex‐valve, respectively), or placebo (n = 110) once daily in the morning. Efficacy was monitored by asthma symptom scores, rescue medication use, morning and evening peak expiratory flow (PEF) measurements, spirometry, and probability of study completion without experiencing lack of efficacy. Results:  Morning PEF remained stable with either ciclesonide dose but decreased with placebo; the differences were significant (P 
ISSN:0105-4538
1398-9995
DOI:10.1111/j.1398-9995.2004.00750.x