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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01459081
First received: October 21, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza A Virus Infection
Influenza B Virus Infection
 Drug: Zanamivir
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Trial of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Resource links provided by NLM:

MedlinePlus related topics: Flu
Drug Information available for: Zanamivir
U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:

Primary Outcome Measures:
  • Time to alleviation of clinically important symptoms [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom score AUC [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Mean symptom scores [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • The use of relief medication [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zanamivir Drug: Zanamivir
10 mg inhaled by mouth, twice daily, for 5 days
Placebo Comparator: Placebo Drug: Placebo
inhaled by mouth, twice daily, for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459081

Locations
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, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Investigators
Principal Investigator: Qingyu Xiu, MD Shanghai Changzheng Hospital
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier: NCT01459081     History of Changes
Other Study ID Numbers: SIM-100
Study First Received: October 21, 2011
Last Updated: January 15, 2013
Health Authority: China: sFDA

Additional relevant MeSH terms:
Influenza, Human
Encephalitis, Herpes Simplex
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Herpesviridae Infections
 DNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Zanamivir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013