Influenza Clinical Trial
Official title:
A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection
This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.
Approximately 636 subjects will be randomized into the Study.
Following confirmation of circulating influenza in the local area, eligible subjects with
recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the
study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will
be randomized to placebo, 40 or 80 mg of laninamivir octanoate.
The study will be conducted on an outpatient basis. The first dose of study drug will be
administered via inhalation within 4 hours of randomization in the clinic, followed by a
second dose at home. Participants will be followed for 14 days to assess efficacy, virology
and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional
PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.
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