NCT03794804已完成不适用
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
Enzymatica AB10 个研究点 分布在 1 个国家目标入组 701 人开始时间: 2019年1月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 701
- 试验地点
- 10
- 主要终点
- WURSS-21 QoL sub score
研究概览
简要总结
This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Age 18 to 70 years old
- •Increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to V1) but generally in good health
- •Readiness to comply with trial procedures, including in particular:
- •Use of IP as recommended
- •Filling in diary
- •Keeping habitual life-style, including diet and physical activity level
- •No use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) during the study (except for the defined "rescue" treatment)
- •Women of child-bearing potential:
- •Have to agree to use appropriate contraception methods
- •Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature,
排除标准
- •Known allergy or hypersensitivity to the components of the investigational product
- •History and/or presence of clinically significant condition/ disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- •Nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery
- •Asthma, chronic obstructive lung disease or any other acute/chronic airways disease/disorder (e.g. chronic cough of any origin)
- •Acute psychiatric disorders
- •Any other acute/chronic serious organ or systemic diseases
- •Influenza vaccination within the last 3 months prior to V1 and during the study
- •Regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1
- •Pregnancy or nursing
- •History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or medication
- •Participation in the present study of a person living in the same household as the subject
- •Inability to comply with study requirements according to investigator's judgement
- •Participation in another clinical study in the 30 days prior to V1 and during the study
研究组 & 干预措施
ColdZyme
Active Comparator
ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.
The IP use should start when following conditions have been fulfilled:
- Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND
- A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache
The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.
干预措施: ColdZyme (Device)
Placebo
Placebo Comparator
Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.
The IP use should start when following conditions have been fulfilled:
- Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND
- A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache
The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.
干预措施: ColdZyme Placebo (Device)
结局指标
主要结局
WURSS-21 QoL sub score
时间窗: Days 1-8 (day 1 is the first day of symptoms)
The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.
次要结局
- Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item(Days 1-8 (day 1 is the first day of symptoms))
- 1. Composite daily severity of all symptoms within the Jackson score(Days 1-8 (day 1 is the first day of symptoms))
- AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)(Days 1-8 (day 1 is the first day of symptoms))
- 2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms(Days 1-4 (day 1 is the first day of symptoms))
- Assessment of symptom sore throat per Sore Throat Scale(Days 1-8)
- Percentage of subjects with confirmed common cold at Visit 2(1-3 days after symptom start)
- Global evaluation of efficacy by subjects and investigators at study end(From enrolment through study completion, maximum 16 weeks)
- AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)(Days 1-8 (day 1 is the first day of symptoms))
- Assessment of symptom intensity(Days 1-4)
- Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose(Days 1-4)
- Assessment of duration of first intense phase(From enrolment through study completion, maximum 16 weeks)
研究者
研究点 (10)
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