Influenza A Virus InfectionPhase 3NCT01459081
Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China
A Phase 3 study testing Zanamivir in people with Influenza A Virus Infection and Influenza B Virus Infection, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza A Virus Infection, Influenza B Virus Infection
- What is being tested?
- Zanamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 12 sitesChina
- Study dates
- Oct 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
The Third Xiangya Hospital Of Central South University
Changsha
West China Hospital, Sichuan University
Chengdu
The First People's Hospital of Hangzhou
Hangzhou
The Affiliated Hospital of Inner Mongolia Medical College
Hohhot
The First Affiliated Hospital of Nanchang University
Nanchang
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Qingdao Municipal Hospital
Qingdao
Shanghai 6th People's Hospital
Shanghai
Shanghai Changzheng Hospital
Shanghai
ShengJing Hospital of China Medical University
Shenyang
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an
Northern Jiangsu People's Hospital
Yangzhou
About this study
Official title: Randomised, Double-blind, Placebo-controlled Trial 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.
- Being tested
- Zanamivir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanamivirDrug
10 mg inhaled by mouth, twice daily, for 5 days
PlaceboDrug
inhaled by mouth, twice daily, for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Zanamivir | Experimental | Not described Receives: Drug: Zanamivir |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to alleviation of clinically important symptoms
Measured: up to 21 days
Secondary outcomes (3)
Symptom score AUC
Measured: 6 days
Mean symptom scores
Measured: 6 days
The use of relief medication
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Virus InfectionStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingyu Xiu, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459081
- Sponsor's protocol ID
- SIM-100
- Status last verified
- Jan 2013
- First submitted
- 21 Oct 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Trial of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China
- ClinicalTrials.gov ID
- NCT01459081
- Acronym / sponsor ID
- SIM-100
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanamivir | Experimental | Drug: Zanamivir |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zanamivir10 mg inhaled by mouth, twice daily, for 5 days | Drug | Zanamivir |
| Placeboinhaled by mouth, twice daily, for 5 days | Drug | Placebo |
Primary outcome
Time to alleviation of clinically important symptoms
Time frame: up to 21 days
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingyu Xiu, MD principal investigator
Shanghai Changzheng Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zanamivir in people with Influenza A Virus Infection and Influenza B Virus Infection, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to alleviation of clinically important symptoms (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.