Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients
Carlos Alberto de Castro Pereira, Flávia Fillardo Vianna, Alberto Cukier, Rafael Stelmach, Júlio César Abreu de Oliveira, Erich Vidal Carvalho, Edimar Pedrosa Gomes, Suzete Varela Mayo, Antônio Monteiro da Silva Chibante, Cláudia Patrícia Domingues, Carlos Alberto de Castro Pereira, Flávia Fillardo Vianna, Alberto Cukier, Rafael Stelmach, Júlio César Abreu de Oliveira, Erich Vidal Carvalho, Edimar Pedrosa Gomes, Suzete Varela Mayo, Antônio Monteiro da Silva Chibante, Cláudia Patrícia Domingues
Abstract
Objective: Mometasone furoate (MF) is a new, potent synthetic inhaled corticosteroid. Worldwide, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, 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 (FEV1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-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.
Trial registration: ClinicalTrials.gov NCT00975741.
Source: PubMed