Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in the Treatment of Acute Infectious Rhinitis in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS)
研究概览
简要总结
Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria. Healsea® Rescue* is indicated in adults for the treatment of symptoms of acute respiratory tract infections, rhinitis or rhinosinusitis, and for reduction of the swelling of the nasal mucosa.
The goal of this clinical trial is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo in adults with early symptoms of common cold / acute infectious rhinitis.
详细描述
Upper respiratory tract infections (URTIs) and sino-nasal symptoms are very frequent, especially during the fall and the winter. The common cold is caused by a variety of viruses such as human rhinoviruses and influenza viruses. The incidence of acute rhinitis/rhinosinusitis is very high, estimated to occur from 2 to 5 times per year in the average adult. However, the natural course of acute rhinitis in adults is favorable since 75% of persons have a reduction or resolution of symptoms within 7 days. Only 0.5 to 2.0% of subjects develop secondary bacterial sinusitis requiring antibiotic prescription. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy. The socioeconomic impact of acute rhinitis is well established: visits to GP, additional prescriptions and over prescription of antibiotics, workdays lost.
Although clinical evidence from well-designed trials is scarce, European and American guidelines for acute rhinosinusitis recommend daily nasal saline irrigation for reduction of the severity of symptoms and for speeding recovery. The exact mechanisms by which nasal irrigation works are not known. However, most of the experts agree that it is primarily a mechanical intervention leading to direct cleansing of the nasal mucosa. Hypertonic saline solutions are generally considered as more effective than isotonic saline solutions in reducing nasal symptoms in the acute phase. Nevertheless, the efficacy of such solution remains moderate.
Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria Bacillus licheniformis T14. The nasal solution is hypertonic (NaCl 2.7%). Symbiofilm™ is an exopolysaccharide with emulsifying properties and in vitro antibiofilm activity and detachment properties against various bacterial pathogens. Symbiofilm™ also protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, Coronavirus OC43 and Flu infection.
The aim of this study is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo.
The study comprises two parts:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female subjects >18 years
- •Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
- •Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a score ≤9 (according to a self-rated symptom score; scale: 0 → 3 [0: no symptom to 3: severe intensity])
- •At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
- •Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form
- •Patient with a smartphone and an internet connection.
排除标准
- •Known hypersensitivity/allergy to any component of the test device
- •Medical history or any current disease that is considered by the investigator as a reason for non-inclusion
- •Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
- •History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
- •Antibiotic intake within 2 weeks before screening
- •Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening
- •Antihistamines intake for allergy when treatment was started from less than 4 weeks
- •Chronic decongestant use
- •Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom score at screening (NSAID, nasal decongestants, cough medicines)
- •Pregnant/Lactating female or absence of efficient contraception
结局指标
主要结局
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS)
时间窗: Treatment period, from Day 1 to Day 8
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calculation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP)
时间窗: Treatment period, from Day 1 to Day 8
The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calulation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
次要结局
- AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days(Treatment period, from Day 1 to Day 8)
- AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days(Treatment period, from Day 1 to Day 8)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion(Through study completion, up to Day 15)
- Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired(Through study completion, up to Day 15)
- Cumulative Number of Days of Usual Medication for Common Cold Use(Through study completion, up to Day 15)
- Subject Satisfaction Regarding Ease of Use of the Nasal Spray(Between Day 13 and Day 15)
- Characterization of Residual Taste by the Subject(Between Day 13 and Day 15)
- Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject(Between Day 13 and Day 15)