ABSTRACT
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 Subject(s)
Asthma/drug therapy
, Indans/administration & dosage
, Metered Dose Inhalers
, Quinolones/administration & dosage
, Administration, Inhalation
, Adolescent
, Adult
, Aged
, Asthma/diagnosis
, Dose-Response Relationship, Drug
, Double-Blind Method
, Drug Administration Schedule
, Female
, Follow-Up Studies
, Humans
, Male
, Middle Aged
, Multivariate Analysis
, Probability
, Reference Values
, Respiratory Function Tests
, Severity of Illness Index
, Spirometry
, Treatment Outcome
