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

NCT01459081 | Completed Phase 3

• 1 other identifier: SIM-100
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 12

Brief 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

Influenza A Virus Infection; Influenza B Virus Infection

Outcome Measures

Primary Outcomes (1)

• Time to alleviation of clinically important symptoms

  up to 21 days

Secondary Outcomes (3)

• Symptom score AUC

  6 days

• Mean symptom scores

  6 days

• The use of relief medication

  6 days

Study Arms (2)

Zanamivir

EXPERIMENTAL

Drug: Zanamivir

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Zanamivir DRUG

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

Zanamivir

Placebo DRUG

inhaled by mouth, twice daily, for 5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (12)

The Third Xiangya Hospital Of Central South University

Changsha, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

The First People's Hospital of Hangzhou

Hangzhou, China

Location

The Affiliated Hospital of Inner Mongolia Medical College

Hohhot, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

Qingdao Municipal Hospital

Qingdao, China

Location

Shanghai 6th People's Hospital

Shanghai, China

Location

Shanghai Changzheng Hospital

Shanghai, China

Location

ShengJing Hospital of China Medical University

Shenyang, China

Location

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, China

Location

Northern Jiangsu People's Hospital

Yangzhou, China

Location

MeSH Terms

Interventions

Zanamivir

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amino Sugars; Carbohydrates

Study Officials

• Qingyu Xiu, MD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

CN (12)