Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Frequency of Influenza-like Illness
研究概览
简要总结
The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female
- •Females of child-bearing potential must practice a medically accepted form of birth control
排除标准
- •Currently exhibiting an acute upper respiratory tract infection
- •history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma, bronchitis, etc.)
- •any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy)
- •any condition requiring regular treatment with antihistamines, analgesics or antipyretics
- •known infection with HIV, hepatitis B virus or hepatitis C virus
- •any other serious, uncontrolled disease
- •any active infections requiring use of antibiotic or antiviral drugs
- •non-ambulatory status
- •suspected drug or alcohol abuse
研究组 & 干预措施
Interferon-alpha
150 international units of interferon-alpha
干预措施: interferon-alpha (Drug)
placebo
placebo lozenges
干预措施: placebo (Other)
结局指标
主要结局
Frequency of Influenza-like Illness
时间窗: 16 weeks
Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).
次要结局
- Symptom Incidence/Severity(16 weeks)
- Impact of Cold/Flu Symptoms(16 weeks)
- Negative Events Related to Cold/Flu Symptoms(16 weeks)
- Incidence/Severity of Viral Respiratory Infections(16 weeks)