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

January 15, 2013 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
inhaled by mouth, twice daily, for 5 days
EXPERIMENTAL: Zanamivir
Drug: Zanamivir
10 mg inhaled by mouth, twice daily, for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to alleviation of clinically important symptoms
Time Frame: up to 21 days
up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom score AUC
Time Frame: 6 days
6 days
Mean symptom scores
Time Frame: 6 days
6 days
The use of relief medication
Time Frame: 6 days
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Qingyu Xiu, MD, Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (ESTIMATE)

October 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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