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Original Research: ASTHMA |

Rapid Effect of Inhaled Ciclesonide in Asthma: A Randomized, Placebo-Controlled Study

Edward M. Erin, MRCP; Angela S. Zacharasiewicz, MD; Grant C. Nicholson, BSc; Andrew J. Tan, RN; Helen Neighbour, MRCP; Renate Engelstätter, PhD; Michael Hellwig, PhD; Onn Min Kon, FRCP; Peter J. Barnes, DM, FCCP; Trevor T. Hansel, FRCPath
Author and Funding Information

*From the National Heart and Lung Institute Clinical Studies Unit (Drs. Erin, Neighbour, and Hansel, Mr. Nicholson, and Mr. Tan), Imperial College, London, UK; Department of Pediatric and Adolescent Medicine (Dr. Zacharasiewicz), Pulmonary and Infectious Diseases, Wilhelminenspital, Vienna, Austria; Nycomed GmbH (Drs. Engelstätter and Hellwig), Konstanz, Germany; St. Mary's Hospital (Dr. Kon), Paddington, London, UK; and Department of Thoracic Medicine (Dr. Barnes), Imperial College, London, UK.

Correspondence to: Trevor T. Hansel, FRCPath, NHLI Clinical Studies Unit, Royal Brompton Hospital, Fulham Rd, London SW3 6HP, UK; e-mail: t.hansel@ic.ac.uk

Edward M. Erin, Angela S. Zacharasiewicz, Grant C. Nicholson, Andrew J. Tan, Helen Neighbour, and Onn M. Kon have no conflicts of interest to disclose. Renate Engelstätter and Michael Hellwig are full-time employees of Nycomed GmbH (formerly ALTANA Pharma). Peter J. Barnes has received research funding from GlaxoSmithKline, AstraZeneca, Novartis, and Boehringer Ingelheim, and is a member of speakers bureaus for GlaxoSmithKline, AstraZeneca, Novartis, Boehringer Ingelheim, and Nycomed GmbH (formerly ALTANA Pharma). Trevor T, Hansel has received research funding from GlaxoSmithKline, Novartis, and Oxagen.


The patients were recruited from the Royal Brompton Hospital, London, UK. Written informed consent was obtained from each patient before the start of the study, and the study protocol was reviewed and approved by an Independent Ethics Committee from the Brompton Harefield and National Heart and Lung Institute, Royal Brompton Hospital, London, UK.

This study was funded and sponsored by Nycomed GmbH (formerly ALTANA Pharma). Editorial support was funded by Nycomed GmbH (formerly ALTANA Pharma).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2008;134(4):740-745. doi:10.1378/chest.07-2575
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Background:  Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma, and it is important to measure the onset of effect of this therapy on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and levels of eosinophils in induced sputum.

Methods:  In a randomized, double-blind, crossover study, 21 patients with mild asthma inhaled ciclesonide 320 μg (ex-actuator) qd, ciclesonide 640 μg (ex-actuator) bid, and placebo for 7 days. Exhaled NO and AHR to adenosine monophosphate (AMP), measured as the provocative concentration of AMP producing a 20% reduction in FEV1 (PC20FEV1), were assessed after inhalation on days 1, 3 and 7. Eosinophil levels in induced sputum were also measured.

Results:  Ciclesonide 320 μg qd and 640 μg bid produced significantly greater improvements in PC20FEV1 compared with placebo on day 1 (within 2.5 h), and on days 3 and 7 (all p < 0.0001). On day 3, both ciclesonide doses significantly reduced exhaled NO levels by − 17.7 parts per billion (p < 0.0001) and – 15.4 parts per billion (p < 0.003) vs placebo, respectively. Significant reductions were maintained during the study with both ciclesonide doses (p < 0.01). A nonsignificant trend towards a decrease in eosinophil cell numbers was observed after 7 days of ciclesonide treatment, especially in patients receiving the higher dose.

Conclusions:  A single dose of ciclesonide decreased AHR to AMP and exhaled NO within 3 h, while FEV, improved at 3 days and 7 days.

Trial registration:  ClinicalTrials.gov Study ID Number BY9010/M1-125.

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