Influenza A Virus Infection, Influenza B Virus Infection
Conditions
Brief summary
The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.
Interventions
DRUGZanamivir
10 mg inhaled by mouth, twice daily, for 5 days
DRUGPlacebo
inhaled by mouth, twice daily, for 5 days
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Who had fever (\>38.0ºC) * At least two of the following symptoms: chills, headache, myalgia, fatigue, nasal symptoms, sore throat, cough * Started therapy within 48 hours of onset of influenza-like illness * Written informed consent
Exclusion criteria
* Respiratory diseases, such as asthma or COPD * Woman with a positive urine pregnancy test * Woman without contraception during the study * Allergic to zanamivir, Paracetamol or lactose * WBC ≥ 10.5×109/L; neutrophil percentage ≥ 80% * Hepatic function impairment: AST ≥ 2×ULN, ALT ≥ 2×ULN * Renal function impairment: Cr \> 221μmol/L * Influenza vaccination in the 12 months prior the beginning of the study * History of tumor, psychiatric disorders, epilepsy or drug abuse * Patients receiving corticosteroids, immunosuppressants * HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to alleviation of clinically important symptoms | up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Symptom score AUC | 6 days |
| Mean symptom scores | 6 days |
| The use of relief medication | 6 days |
Countries
China
Outcome results
None listed