• Sao Paulo Med J · May 2022

    Randomized Controlled Trial

    A randomized clinical trial on inhaled ciclesonide for managing acute asthma in the emergency room.

    • Demétrius Tierno Martins, Karla Carlos, Luciane Bizari Carvalho, Lucila Bizari Prado, Carolina Fransolin, Alvaro Nagib Atallah, and PradoGilmar Fernandes doGFD0000-0002-3383-8198MD, PhD. Professor, Neuro-Sono Sleep Center, Department of Neurology, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil..
    • MD. Physician, Department of Emergency Medicine and Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil.
    • Sao Paulo Med J. 2022 May 1; 140 (3): 430438430-438.

    BackgroundUse of inhaled corticosteroids for managing acute asthma exacerbations has been tested since the 1990s.ObjectiveTo compare high doses of inhaled ciclesonide with systemic hydrocortisone for managing acute asthma exacerbations in the emergency department.Design And SettingDouble-blind, randomized clinical trial in the public healthcare system of the city of São Paulo.MethodsFifty-eight patients with moderate or severe asthma with peak flow < 50% of predicted were randomized into two groups. Over the course of four hours, one group received 1440 mcg of inhaled ciclesonide plus hydrocortisone-identical placebo (ciclesonide + placebo), while the other received 500 mg of intravenous hydrocortisone plus ciclesonide-identical placebo (hydrocortisone + placebo). Both groups received short-acting bronchodilators (fenoterol hydrobromide and ipratropium bromide). The research protocol included spirometry, clinical evaluation, vital signs and electrocardiogram monitoring. Data were obtained at 30 (baseline), 60, 90, 120, 180, and 240 minutes. We compared data from baseline to hour 4, between and within groups.ResultsOverall, 31 patients received ciclesonide + placebo and 27 received hydrocortisone + placebo. Inhaled ciclesonide was as effective as intravenous hydrocortisone for improving clinical parameters (Borg-scored dyspnea, P = 0.95; sternocleidomastoid muscle use, P = 0.55; wheezing, P = 0.55; respiratory effort, P = 0.95); and spirometric parameters (forced vital capacity, P = 0.50; forced expiratory volume in the first second, P = 0.83; peak expiratory flow, P = 0.51).ConclusionsInhaled ciclesonide was not inferior to systemic hydrocortisone for managing acute asthma exacerbations, and it improved both clinical and spirometric parameters.Trial RegistrationRBR-6XWC26 - Registro Brasileiro de Ensaios Clínicos (http://www.ensaiosclinicos.gov.br/rg/RBR-6xwc26/).

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