NCT01793883

Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 639 (actual)
• Sponsor: Biota Scientific Management Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	40 mg Laninamivir Octanoate
DRUG	80 mg Laninamivir Octanoate
DRUG	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-02-18
• Last updated: 2018-05-31
• Results posted: 2017-09-01

Locations

221 sites across 16 countries: United States, Australia, Belgium, Bulgaria, Canada, Colombia, Estonia, France, Germany, Hungary, Latvia, Mexico, New Zealand, Peru, South Africa, United Kingdom