Efficacy and safety of two dry-powder inhalers for the administration of mometasone furoate in asthma patients.
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.
Pereira
Carlos Alberto de Castro
CA
Clínica de Pneumologia, Hospital do Servidor Público Estadual, São Paulo, Brasil. pereirac@uol.com.br
Vianna
Flávia Fillardo
FF
Cukier
Alberto
A
Stelmach
Rafael
R
Oliveira
Júlio César Abreu de
JC
Carvalho
Erich Vidal
EV
Gomes
Edimar Pedrosa
EP
Mayo
Suzete Varela
SV
Chibante
Antônio Monteiro da Silva
AM
Domingues
Cláudia Patrícia
CP
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D058995:Dry Powder Inhalers / Q000379:methods / Q000592:standards*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate