Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Physicians' assessment of change of intensity of rhinosinusitis symptoms
研究概览
简要总结
The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray.
It will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin Nasal Douche as concomitant therapy.
详细描述
The current non-interventional study aims to investigate the efficacy, tolerability and safety of a decongestant Xylometazoline-containing nasal spray in comparison to use of a decongestant Xylometazoline-containing nasal spray together with an Ectoin-containing nasal douche in patients with acute viral rhinosinusitis.
Efficacy will be studied by documentation of the following symptoms:
- oedema, redness (assessed by rhinoscopy)
- nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste
- sore throat, cough
In parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries.
Patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. The assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute viral rhinosinusitis
- •presence of common cold symptoms
排除标准
- •contraindications in accordance with instructions for use
- •acute bacterial rhinosinusitis
- •chronic rhinosinusitis
研究组 & 干预措施
Xylometazoline + Ectoin Nasal Douche
Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required
干预措施: Xylometazoline Nasal Spray (Drug)
Xylometazoline Nasal spray
1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day
干预措施: Xylometazoline Nasal Spray (Drug)
Xylometazoline + Ectoin Nasal Douche
Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required
干预措施: Ectoin Nasal Douche (Device)
结局指标
主要结局
Physicians' assessment of change of intensity of rhinosinusitis symptoms
时间窗: day 0 and day 7 and (if necessary, depending on study duration) and on day 14
Both on day 0 and on day 7 (and, if necessary, depending on study duration, on day 14), the physicians will assess rhinosinusitis symptoms oedema, redness of the nose, nasal obstruction, nasal secretion, facial pain/headache, smell/taste dysfunction and the concomitant symptoms dryness of the nasal mucosa and sore throat. Assessment will be carried out based on a 5-point scale (0=none to 4=very strong). Change of symptoms will be assessed comparing symptom scores on day 7 (or day 14, if applicable) to day 0. The investigators will use rhinoscopy, physical examination and interview of the patients for the assessments.
次要结局
- Patients' assessment of intensity of symptoms and their influence on quality of life(7 to 14 days (depending on study duration))
- Assessment of the efficacy of treatments(day 7 or day 14 (depending on study duration))
- Assessment of the tolerability of treatments(day 7 or day 14 (depending on study duration))
- Physicians' assessment of general well-being of patients(day 0 and day 7 and day 14 (if necessary, depending on study duration))
- Incidence of adverse events/serious adverse events(7 to 14 days (depending on study duration))