Influenza A and B virus infected patient with chronic respiratory disease(asthma, COPD, pulmonary fibrosis)
Conditions
Interventions
peramivir 600mg 2days dosing
peramivir 300mg single-dosing
oseltamivir 75mg bid 5days
Sponsors
Shionogi&Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Both Inpatient and outpatient 2)Patients with influenza symptoms confirmed by all of the following, Influenza rapid diagnosis test:positive Fever more than or qual 37.5 degree (axillary) during the predose examinations or more than 4 hours after dosing of antipyretics if they were taken. Patients showing at least total of 3 points of respiratory symptoms (cough, sore throat, nasal congestion) associated At least more than 2 points (moderate) of one general symptom (either headache, feverishness or chills, muscle or joint pain, or fatigue) 3)The time interval between the onset of symptoms and the predose examinations (Screening)is 48 hours or less.
Exclusion criteria
Exclusion criteria: 1)Patients who need antibacterial or antifungal or antiviral drugs for treatment of underlying dieases 2)patients with chronic respiratory who had been in ventilator settings 3)patients receving dialysis or with impaired renal function (Ccr<50mL/min) 4)within previously 7days, patients who were treated with either of 4NA inhibitor (oseltamivir, zanamivir, peramivir and laninamivir)and amantadine 5)pregnant, breast-feeding woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of influenza respiratory symptom score until 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Respiratory symptom score at every 24hrs, Duration of influenza illness, Duration of fever, Respiratory functional capability, Exacerbation incidence, Virus titer, AE and ADR incidences | — |
Countries
Japan
Contacts
Public ContactYutaka Saisho
Shionogi&Co.,LTD Medical Affairs
Outcome results
None listed