Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Influenza A Virus Infection Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled Trial of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459081
• Other study ID #: SIM-100
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2011
• Last updated: January 15, 2013
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: sFDA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza A Virus Infection
• Influenza B Virus Infection
• Influenza, Human
• Virus Diseases

Intervention

Drug:
• Zanamivir
10 mg inhaled by mouth, twice daily, for 5 days
• Placebo
inhaled by mouth, twice daily, for 5 days

Locations

Country	Name	City	State
China	The Third Xiangya Hospital Of Central South University	Changsha
China	West China Hospital, Sichuan University	Chengdu
China	The First People's Hospital of Hangzhou	Hangzhou
China	The Affiliated Hospital of Inner Mongolia Medical College	Huhehaote
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing
China	Qingdao Municipal Hospital	Qingdao
China	Shanghai 6th People's Hospital	Shanghai
China	Shanghai Changzheng Hospital	Shanghai
China	ShengJing Hospital of China Medical University	Shenyang
China	Tangdu Hospital Affiliated to the Fourth Military Medical University	Xi'an
China	Northern Jiangsu People's Hospital	Yangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to alleviation of clinically important symptoms		up to 21 days	No
Secondary	Symptom score AUC		6 days	No
Secondary	Mean symptom scores		6 days	No
Secondary	The use of relief medication		6 days	No