CompletedNCT01459081Updated Jan 16, 2013

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

A Phase 3 interventional study of Zanamivir and Placebo in Influenza A Virus Infection and Influenza B Virus Infection, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Completed at 12 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-16.

Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 298
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Influenza A Virus Infection
Influenza B Virus Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 298 is above the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 298 participants (actual)

Study arms

Experimental
Zanamivir
Drug: Zanamivir
Placebo comparator
Placebo
Drug: Placebo

Interventions

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

What researchers measure

Primary outcomes

Time to alleviation of clinically important symptoms
Time frame: up to 21 days

Secondary outcomes

Symptom score AUC
Time frame: 6 days
Mean symptom scores
Time frame: 6 days
The use of relief medication
Time frame: 6 days

Study locations

12 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01459081
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Oct 25, 2011
Start date: Oct 2011
Primary completion: Dec 2012
Completion: Dec 2012
Last update: Jan 16, 2013

Study contacts

Qingyu Xiu, MD

principal investigator · Shanghai Changzheng Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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