Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza (Igloo)
|Influenza||Drug: 40 mg Laninamivir Octanoate Drug: 80 mg Laninamivir Octanoate Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|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|
- Time to Alleviation of Influenza Symptoms [ Time Frame: Efficacy will be assessed over 14 days post-randomization. ]Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.
|Study Start Date:||May 2013|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 40 mg Laninamivir Octanoate DPI
40 mg Laninamivir Octanoate and matching placebo
Drug: 40 mg Laninamivir Octanoate
Other Name: CS-8958Drug: Placebo
Other Name: Lactose
Active Comparator: 80 mg Laninamivir Octanoate DPI
80 mg Laninamivir
Drug: 80 mg Laninamivir Octanoate
Other Name: CS-8958
Placebo Comparator: Placebo
Other Name: Lactose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793883
Show 221 Study Locations
|Study Director:||John Lambert, PhD||Biota Scientific Management Pty Ltd|