Conditions: Influenza, Human
Keywords: Influenza Neuraminidase inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1002
Healthy volunteers: no

Brief summary:
The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.

In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.

Detailed description:

Arms:
arm 1: CS-8958 powder to be inhaled - low-dose arm arm 2: CS-8958 powder to be inhaled - high-dose arm arm 3: oseltamivir phosphate oral capsules

Interventions: intervention 1: CS-8958 intervention 2: CS-8958 intervention 3: oseltamivir phosphate
Intervention descriptions: intervention 1: CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days intervention 2: CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days intervention 3: CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.

Protocol document: