NCT05159271已完成不适用
Efficacy and Safety of Azeol Nasal Spray Versus Placebo in the Treatment of Early Symptoms of Common Cold in Adults: the EXSPRAY Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Larena SAS
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- relief of nasal congestion at 2 days
研究概览
简要总结
The main objective is to evaluate the efficacy of Azéol Spray Nasal, taken two times a day, versus placebo on nasal congestion in subject with common cold.
详细描述
This study is designed as a multicentric, randomized, double-blind, placebo-controlled with two-arm parallel groups clinical trial. 144 subjects presenting with early symptoms of common cold will be recruited for this study, according to the defined inclusion and exclusion criteria. The main objective is to evaluate the efficacy of Azéol Spray Nasal (Bifidobacterium breve LA 708, extract of cypres Cupressus sempervirens L., extract of Leguminosae Glycyrrhiza glabra L., glycerin and mannitol), taken two times a day, versus placebo on nasal congestion in subject with common cold.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged between 18 and 65 years (limits included); I
- •Subjects with early symptoms of common cold (onset less than or equal to 48 hours before inclusion upon subjects' declaration);
- •Subjects with:
- •A minimum nasal congestion score (blocked nose) of 2 (moderate) according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert scale,
- •Presenting a minimum of two common cold symptoms (runny nose, blocked nose, sore throat, and/or cough) at inclusion visit (V1) assessed with a score ≥ 1 according to a 4-point scale (0 not present; 1 mild; 2 moderate; and 3 severe) assessed by Likert,
- •Minimum plugged nose (nasal congestion) score of 3 (≥ 3) assessed by WURSS-21;
- •Non menopausal with the same reliable contraception since at least 2 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel, any oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, surgical intervention (bilateral tubal ligation or ovariectomy or hysterectomy), ESSURE system),
- •Menopausal without or with hormone replacement therapy; I
- •Subject with good general and mental health according to the investigator opinion: no clinically significant and relevant abnormalities of medical history or physical examination; I
- •Subject able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form; I
- •Subject affiliated with a social security scheme; I
- •Subject who agree to be registered on the volunteers in biomedical research file.
排除标准
- •Subjects with nasal polyps/polyposis or nasal septum malformations or other nasal structural abnormalities that would compromise administration of the nasal spray (based on the declaration of the subjects); E
- •Subjects with any other acute ear, nose, and throat and respiratory tract disease than the common cold (eg, tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic rhinitis; E
- •Subject suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, or other chronic respiratory trouble, etc.);
- •Subject under:
- •Concomitant treatment that might impair the trial results (eg, decongestants, local anesthetics, topical corticosteroids, saline solution) during the seven days prior to enrollment in the trial,
- •Cough treatment or NSAID or any other treatment for the common cold during the seven days prior to enrollment in the trial,
- •Any dietary supplement or probiotic; E
- •Subjects with known or suspected hypersensitivity to the investigational device ingredients or to ingredients which could cause crossed allergia as cypress, peach or citrus fruit; E
- •Subjects not fully vaccinated against SARS-CoV-2 virus; E
- •Subjects positive for SARS-CoV-2 tested by rapid antigen test at V1; E
- •Subjects with fever ≥ 38 °C; E
- •Pregnant or lactating women or intending to become pregnant within the month ahead and during the whole study;
- •Having a lifestyle deemed incompatible with the study according to the investigator as described below:
- •Consuming more than 2 standard drinks of alcoholic daily or 14 weekly or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
- •Smoking more than five cigarettes daily or more than 60 mg of nicotine daily,
- •Practicing high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded); E
- •Subject taking part in another clinical trial or being in the exclusion period of a previous clinical trial; E
- •Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; E
- •Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; E
- •Subject presenting a psychological or linguistic inability to sign the informed consent;
结局指标
主要结局
relief of nasal congestion at 2 days
时间窗: 2 days
change from baseline in the relief of nasal congestion defined by "plugged nose", after 2 days of product intake, assessed at end of day after both spraying sessions with the "plugged nose" question
次要结局
- relief of nasal congestion(7 days)
- Area Under the Curve for sick feeling score, global severity score, symptom score and for quality-of-life score(7 days)
- Area Under the Curve for nine quality-of-life items(7 days)
- Time to onset of subjective relief nasal congestion from day 1(7 days)
- Subject's assessment of common cold feeling compared to the day before(7 days)
- Area Under the Curve for common cold symptoms(7 days)
- Subjects' assessment of efficacy(7 days)
- Presence of secondary infections in the month after the D7(1 month after D7)
- Area Under the Curve for the total nasal airway resistance to airflow(First day)
- Time to onset of subjective relief symptoms from day 1(7 days)
研究者
研究点 (4)
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