Randomized double-blind clinical trial on inhaled ciclesonide for asthma treatment: efficacy, effectiveness and impact on sleep

• Grant number: 09/16758-4
• Support type: Regular Research Grants
• Duration: December 01, 2010 - May 31, 2013
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal researcher: Gilmar Fernandes Do Prado
• Grantee: Gilmar Fernandes Do Prado
• Home Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
• Assoc. researchers: Ana Luisa Godoy Fernandes ; Demetrius Tierno Martins

Abstract

Randomized double-blind clinical trial on inhaled ciclesonide for asthma treatment: efficacy, effectiveness and impact on sleepPrincipal investigator: Prof. Dr. Gilmar Fernandes do Prado.Main institution: Universidade Federal de São Paulo - Escola Paulista de MedicinaBronchial asthma is a chronic inflammatory process that changes the activities of daily living. It is associated with insomnia and obstructive sleep apnea syndrome (OSAS), with periods of exacerbation that, if untreated, may lead to death.There is interest in the literature in drugs that could be used to treat asthma crises and improve the quality of sleep among asthmatic patients.High doses of inhaled corticoids are used to treat asthma crises because of their topical anti-inflammatory effect and rapid onset. They are associated with improvements in peak expiratory flow and expiratory volume in the first second and an earlier end to the emergency than with endovenous corticoids.Other inhaled corticoids seem to be associated with myopathy of the pharyngeal dilators, thereby favoring OSAS. Inhaled ciclesonide has not been tested for treating acute asthma, and its impact on asthmatic individuals' sleep has also not been investigated. Its high ani-inflammatory potency, elevated pulmonary deposition and low systemic absorption provide justification for exploring this therapeutic resource in relation to asthma crises, quality of sleep and OSAS. This study had the aim of investigating the efficacy and efficiency of inhaled ciclesonide for asthma treatment and its effects relating to sleep, rehospitalization, adherence and crises, with 14 days of follow-up. (AU)