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NCT Number: NCT01459081

Efficacy and Safety 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.

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Key information

Conditions

Influenza A Virus Infection Influenza B Virus Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Third Xiangya Hospital Of Central South University, Changsha, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zanamivir

Drug

10 mg inhaled by mouth, twice daily, for 5 days

Placebo

Drug

inhaled by mouth, twice daily, for 5 days

Primary outcomes

  1. Time to alleviation of clinically important symptoms

    Time frame: up to 21 days

Secondary outcomes

  1. Symptom score AUC

    Time frame: 6 days

  2. Mean symptom scores

    Time frame: 6 days

  3. The use of relief medication

    Time frame: 6 days

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2011
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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