search
Back to results

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

Primary Purpose

Influenza A Virus Infection, Influenza B Virus Infection

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Zanamivir
Placebo
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza A Virus Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Third Xiangya Hospital Of Central South University
  • West China Hospital, Sichuan University
  • The First People's Hospital of Hangzhou
  • The Affiliated Hospital of Inner Mongolia Medical College
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Nanjing Medical University
  • Qingdao Municipal Hospital
  • Shanghai 6th People's Hospital
  • Shanghai Changzheng Hospital
  • ShengJing Hospital of China Medical University
  • Tangdu Hospital Affiliated to the Fourth Military Medical University
  • Northern Jiangsu People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zanamivir

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time to alleviation of clinically important symptoms

Secondary Outcome Measures

Symptom score AUC
Mean symptom scores
The use of relief medication

Full Information

First Posted
October 21, 2011
Last Updated
January 15, 2013
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01459081
Brief Title
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China
Official Title
Randomised, Double-blind, Placebo-controlled Trial of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Virus Infection, Influenza B Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zanamivir
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zanamivir
Intervention Description
10 mg inhaled by mouth, twice daily, for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
inhaled by mouth, twice daily, for 5 days
Primary Outcome Measure Information:
Title
Time to alleviation of clinically important symptoms
Time Frame
up to 21 days
Secondary Outcome Measure Information:
Title
Symptom score AUC
Time Frame
6 days
Title
Mean symptom scores
Time Frame
6 days
Title
The use of relief medication
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyu Xiu, MD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Xiangya Hospital Of Central South University
City
Changsha
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
The First People's Hospital of Hangzhou
City
Hangzhou
Country
China
Facility Name
The Affiliated Hospital of Inner Mongolia Medical College
City
Huhehaote
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
Country
China
Facility Name
Shanghai 6th People's Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
Country
China
Facility Name
ShengJing Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
Tangdu Hospital Affiliated to the Fourth Military Medical University
City
Xi'an
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs