• Chest · Oct 2008

    Randomized Controlled Trial

    Rapid effect of inhaled ciclesonide in asthma: a randomized, placebo-controlled study.

    • Edward M Erin, Angela S Zacharasiewicz, Grant C Nicholson, Andrew J Tan, Helen Neighbour, Renate Engelstätter, Michael Hellwig, Onn Min Kon, Peter J Barnes, and Trevor T Hansel.
    • National Heart and Lung Institute Clinical Studies Unit, Imperial College, London, UK.
    • Chest. 2008 Oct 1; 134 (4): 740-745.

    BackgroundCiclesonide 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.MethodsIn a randomized, double-blind, crossover study, 21 patients with mild asthma inhaled ciclesonide 320 microg (ex-actuator) qd, ciclesonide 640 microg (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.ResultsCiclesonide 320 microg qd and 640 microg 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.ConclusionsA single dose of ciclesonide decreased AHR to AMP and exhaled NO within 3 h, while FEV, improved at 3 days and 7 days.

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