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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:
ClinicalTrials.gov Identifier:
NCT01459081
First Posted: October 25, 2011
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Time to alleviation of clinically important symptoms [ Time Frame: up to 21 days ]

Secondary Outcome Measures:
  • Symptom score AUC [ Time Frame: 6 days ]
  • Mean symptom scores [ Time Frame: 6 days ]
  • The use of relief medication [ Time Frame: 6 days ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Co., Ltd.
Investigators
Principal Investigator: Qingyu Xiu, MD Shanghai Changzheng Hospital
  More Information

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01459081     History of Changes
Other Study ID Numbers: SIM-100
First Submitted: October 21, 2011
First Posted: October 25, 2011
Last Update Posted: January 16, 2013
Last Verified: January 2013

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