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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: The rainbow study
Respiratory Medicine, Volume 104, No. 11, Year 2010
Notification
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Description
Objective: To evaluate the efficacy and safety of three doses of ciclesonide (with or without spacer) in children with persistent asthma. Patients and methods: This was a multicentre, double-blind, placebo-controlled, 12-week study of ciclesonide 40, 80 or 160 μg (once daily pm). Children (6-11 years) were randomised 1:1 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. The primary variable was change from baseline in mean morning peak expiratory flow (PEF). Secondary variables included: time to first lack of efficacy (LOE), asthma control, forced expiratory volume in 1 s (FEV 1), asthma symptom score and quality of life (QoL). Safety assessments included: adverse events (AEs), urinary cortisol excretion and body height. Results: In total, 1073 children received treatment. At endpoint, mean morning PEF significantly improved with all doses of ciclesonide vs. placebo. There was no difference over placebo in time to first LOE, but ciclesonide was superior to placebo on asthma control, symptom score, FEV1 and QoL. There were no differences between the spacer or non-spacer subgroups. The incidences of AEs were comparable between treatment groups (approximately 35%) and there were no between-group differences in body height or urinary cortisol. Conclusions: Ciclesonide 40-160 μg once daily is effective and well tolerated in children with persistent asthma; its efficacy and safety are unaffected by the use of a spacer. clinicaltrials.gov registration number: NCT00384189. © 2010 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Pedersen, Soøren Erik
Denmark, Odense
Syddansk Universitet
Potter, Paul C.
South Africa, Cape Town
University of Cape Town Lung Institute
Dachev, Svetoslav
Bulgaria
District Hospital for Pulmonary Diseases
Bosheva, Miroslava
Bulgaria, Plovdiv
Medical University of Plovdiv
Kaczmarek, Jadwiga
Poland, Lodz
Uniwersytecki Szpital Kliniczny nr 1 Im. Norberta Barlickiego w Lodz
Springer, Ewa
Poland, Poznan
Snzoz Alergologia Plus
Dunkel, Jochen
Germany, Konstanz
Nycomed Gmbh
Engelstätter, Renate
Germany, Konstanz
Nycomed Gmbh
Statistics
Citations: 8
Authors: 8
Affiliations: 7
Identifiers
Doi:
10.1016/j.rmed.2010.06.012
ISSN:
09546111
Research Areas
Disability
Maternal And Child Health