RESUMO
BACKGROUND: Indacaterol is a novel, once-daily beta(2)-agonist in development for the treatment of asthma and chronic obstructive pulmonary disease. Studies were required to determine optimal dose(s) for continuing investigation. OBJECTIVE: A dose-ranging study was undertaken to evaluate efficacy and safety of indacaterol. METHODS: A total of 436 patients with persistent asthma receiving inhaled corticosteroids were randomized to 7 days treatment with once-daily indacaterol 50, 100, 200, or 400 microg via multi-dose dry-powder inhaler (MDDPI; Certihaler), indacaterol 400 microg via single-dose dry-powder inhaler (SDDPI), or placebo. Serial 24-h spirometry was performed on days 1 and 7. Vital signs, laboratory evaluations, and adverse events were monitored. RESULTS: All doses of indacaterol increased the mean time-standardized area under the curve of forced expiratory volume in 1 s (FEV(1)) from 22 to 24 h postdose (P Assuntos
Asma/tratamento farmacológico
, Indanos/administração & dosagem
, Inaladores Dosimetrados
, Quinolonas/administração & dosagem
, Administração por Inalação
, Adolescente
, Adulto
, Idoso
, Asma/diagnóstico
, Relação Dose-Resposta a Droga
, Método Duplo-Cego
, Esquema de Medicação
, Feminino
, Seguimentos
, Humanos
, Masculino
, Pessoa de Meia-Idade
, Análise Multivariada
, Probabilidade
, Valores de Referência
, Testes de Função Respiratória
, Índice de Gravidade de Doença
, Espirometria
, Resultado do Tratamento