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临床试验/NCT05264350
NCT05264350已完成不适用

A Prospective, Multicenter, Randomized, Controlled, Blinded Post-Market Clinical Follow-up Investigation to Verify Clinical Efficacy, Performance, and Safety of Viiral® Nasal Spray, Compared to Control, When Used According to Intended Use in Subjects With Dry Nose Symptoms

Viiral Nordic AB4 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
4
主要终点
Rhinitis Sicca Symptom Score (RSSS)

研究概览

简要总结

A chronic irritation of the nasal mucosa can be painful and unpleasant for the individual. Dry nasal mucosa with scabs is a common problem but not everyone seeks care. The causes can be several such as staying for long periods in dry and dusty air, hot rooms or hot environments, tobacco smoke, side effects of drugs and mechanical irritation (nasal congestion). The nasal spray contains salic acid (neuraminic acid). This substance is found naturally in humans in the nasal mucosa which keeps it moist. Salic acid is also found, for example, in breast milk and is also found in food production. Previous studies have shown that treatment with salic acid is gentle, relieves symptoms and has a soothing and moisturising effect.

The purpose of the study is to evaluate whether the symptoms of dry nose can be improved with treatment with Viiral®Nasal spray and have a soothing and moisturising effect. The treatment also aims to prevent colds caused by viruses.

As a control product in the study, a nasal spray with isotonic saline solution will be used. In this study, a total of 78 women and men who have been diagnosed with dry nose / rhinitis sicca will be included in the study. After the participants have given their consent to participate in the study, treatment with the study product or control product will begin. The treatment is started by the study participants themselves at home. Two thirds will be treated with the study product and one third will be treated with a control product. Clinic visits will be performed at three occasions after the screening/baseline visit, at day 14, day 28 and on day 56.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed Informed Consent Form.
  • Adult males and females ≥ 18 years old.
  • Score of at least 10 as indication for application of moistening nasal sprays per investigator judgement, confirmed with a total Rhinitis Sicca Symptom Score (sensation of dry nose, nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, runny nose, thick nasal discharge, dry throat, impairment of smell and impairment of sleep) using a 5-point severity scale (0=none, 1=mild, 2=moderate, 3=strong, and 4 = very strong.
  • Able to use the device independently.

排除标准

  • Antiallergy drugs and rhinitis medication, including rescue medication for symptom relief and anti-hyperactivity last week.
  • Pregnancy or lactation at time of investigation participation.
  • Physical or mental impairment affecting subjects' ability to use the device, per investigator judgement.
  • Person not suitable for the investigation according to the investigator judgement.

结局指标

主要结局

Rhinitis Sicca Symptom Score (RSSS)

时间窗: Up to 8 weeks.

RSSS score constitutes of the sum of ten (10) individual symptoms. Each symptom assessed on 5-point scale (0 = none, 1 = mild, 2 = moderated, 3 = strong, 4 = very strong). 1. Sensation of dry nose 2. Impairment of nasal breathing/nasal obstruction 3. Crusting 4. Itching/ sneezing attacks 5. Pain in the nose 6. Nasal discharge anterior/runny nose 7. Thick nasal discharge 8. Desire to clear one's throat /dry throat 9. Impairment of smell 10. Impairment of sleep

次要结局

  • Endoscopy score of the nasal cavity (ES)(Up to 8 weeks.)
  • Nasal spray sensory scale (NSSS)(Up to 8 weeks.)
  • Episodes of common cold/sick days(Up to 8 weeks.)
  • Short Form 12 (SF-12)(Up to 8 weeks.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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