Abstract
Background: Current guidelines for management of acute asthma exacerbations advocate the administration of short-acting bronchodilators and systemic corticosteroids. The use of inhaled corticosteroids for this purpose has been tested since the 1990s, but the optimal agent, dose, and strategy have yet to be defined. Within the context, we designed a double-blind, randomized clinical trial aiming to compare high doses of inhaled ciclesonide to systemic corticosteroids in the treatment of acute asthma exacerbations in the emergency department. Methods: This double-blind, randomized clinical trial enrolled 58 patients with a clinical diagnosis of bronchial moderate and severe asthma by GINA(Global Initiative for Asthma) criteria who presented to the emergency department with peak flow <50% of predicted. Patients were randomized into two groups. Over the course of 4 hours, one group received 1440 mcg inhaled ciclesonide plus hydrocortisone-identical placebo (ciclesonide + placebo group), while the other received 500 mg intravenous hydrocortisone plus ciclesonide-identical placebo (hydrocortisone + placebo group). Both groups received short-acting bronchodilators (fenoterol hydrobromide and ipratropium bromide) as recommended by GINA. The research protocol included spirometry, rigorous and frequent clinical evaluation (dyspnea, accessory muscle use, wheezing, respiratory effort), and vital signs and ECG monitoring. Data were obtained at baseline, 30, 60, 90, 120, 180, and 240 minutes. We compared data from baseline to hour 4 between and within groups. Results: Overall, 31 patients received ciclesonide + placebo and 27 received hydrocortisone + placebo. Inhaled ciclesonide was as effective as intravenous hydrocortisone in 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).Conclusions: Inhaled ciclesonide was non-inferior to systemic hydrocortisone for management of acute asthma exacerbations, improving both clinical and spirometric parameters.Trial registration: RBR-6XWC26 - Registro Brasileiro de Ensaios Clínicos (http://www.ensaiosclinicos.gov.br/rg/RBR-6xwc26/). Date of registration: 05/01/2016 'retrospectively registered'.
Acute asthma exacerbations in emergency department
