Eficácia e segurança de dois inaladores de pó seco usados para a aplicação de furoato de mometasona em pacientes com asma

Abstract

Objective: Mometasone furoate (MF) is a new potent synthetic inhaled corticosteroid. Internationally, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more costeffective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. Methods: A randomized, multicenter, open-label, parallel-group clinical trial involving 74 adult patients with moderate persistent asthma who were randomized into two groups to receive approximately 400 µg of MF once a day for 60 days, either via the multiple-dose inhaler or via the newly developed single-dose inhaler. Results: No significant differences were observed between the two groups regarding the primary endpoints (FEV 1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamicpituitary-adrenal axis function). Conclusions: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma.Keywords: Anti-asthmatic agents; Pregnadienediols; Metered dose inhalers. ResumoObjetivo: O furoato de mometasona (FM) é um novo corticosteroide inalatório sintético potente. Internacionalmente, o FM é fornecido em um inalador de pó seco que permite sua administração em múltiplas doses. Para se obter uma preparação com melhor relação custo-eficácia, foram desenvolvidas no Brasil formulações de FM em cápsulas de pó seco para serem administradas em dose única. O presente estudo teve como objetivo avaliar a eficácia e a segurança dos dois inaladores usados para a administração de FM em pacientes asmáticos. Métodos: Estudo clínico, aberto, comparativo, paralelo e multicêntrico com 74 adultos portadores de asma persistente e moderada, randomizados em dois grupos para receber FM em uma dose de aproximadamente 400 µg, fornecida por um inalador de dose múltipla ou pelo novo inalador de dose única, uma vez ao dia durante 60 dias. Resultados: Não foram observadas diferenças significantes entre os dois grupos estudados nos desfechos primários (VEF 1 e frequência do uso de medicação de resgate) ou nos desfechos secundários (PFE matinal, tolerabilidade e segurança, essa última avaliada pelo estudo do eixo hipotálamo-hipófise-adrenal). Conclusões: A administração de FM com o novo inalador de dose única desenvolvido no Brasil tem eficácia e segurança comparáveis à administração com o inalador de dose múltipla no tratamento de pacientes asmáticos.

Airway disease: similarities and differences between asthma, COPD and bronchiectasis

“…In asthma, inhaled corticosteroids are the mainstay of disease treatment and are considered the first-line treatment in patients with persistent asthma. ICs can reduce the number of exacerbations, improve lung function and quality of life, control respiratory symptoms and decrease the bronchial hyperresponsiveness (102)-(104). Current guidelines emphasize the use of an IC in the initial therapy of patients with asthma symptoms.…”

A survey of recently published cardiovascular, hematological and pneumological original articles in the Brazilian scientific press

“…Melo et al110 determined the lung age of patients with morbid obesity and compared it with the chronological age of these patients, emphasizing the premature damage that morbid obesity does to the lungs. Pereira et al111 evaluated the efficacy and safety of two inhalers for Mometasone furoate administration in patients with asthma and find that the use of the single-dose inhaler developed in Brazil is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma. Pinheiro et al112 compared the effects of early vs. late tracheostomy in patients with acute severe brain injury and conclude that early tracheostomy should be considered a first choice for patients with acute severe brain injury.…”