Non-interventional Study in Patients With Acute Rhinosinusitis to Study Efficacy and Tolerability of Ectoin Rhinosinusitis Nasal Spray, a Xylometazoline-containing Nasal Spray or a Combination of Both.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 168
- 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 and tolerability of an Ectoin containing Rhinosinusitis Nasal Spray (SNS01). Within the study, SNS01 will be used either alone as monotherapy or as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray. A control group will use a Xylometazoline-containing decongestant nasal spray as monotherapy.
It will be investigated if the dose of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occurring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin containing Rhinosinusitis Nasal Spray as concomitant therapy.
详细描述
The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin containing Rhinosinusitis Nasal Spray (SNS01) in patients with acute rhinosinusitis. Patients can chose one of three treatment options: a) Ectoin containing Rhinosinusitis Nasal Spray (SNS01), b) decongestant Xylometazoline-containing nasal spray or c) Ectoin containing Rhinosinusitis Nasal Spray (SNS01) and a decongestant Xylometazoline-containing nasal spray.
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 Spray
Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Spray (SNS01): 1-2 sprays per nostril several times a day
干预措施: Ectoin Rhinosinusitis Nasal Spray (Device)
Ectoin Rhinosinusitis Nasal Spray
application of 1-2 sprays of SNS01 into each nostril several times a day
干预措施: Ectoin Rhinosinusitis Nasal Spray (Device)
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 Spray
Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Spray (SNS01): 1-2 sprays per nostril several times a day
干预措施: Xylometazoline Nasal Spray (Drug)
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
- Physicians' assessment of general well-being of patients(day 0 and day 7 and day 14 (if necessary, depending on study duration))
- Patients' assessment of intensity of symptoms and their influence on quality of life(7 to 14 days (depending on study duration))
- Assessment of the tolerability of treatments(once on day 7 or once on day 14 of treatment (depending on study duration))
- Investigators' and patients' assessment of efficacy of treatments(once on day 7 or day 14 (depending on study duration))
- Incidence of adverse events/serious adverse events(7 to 14 days (depending on study duration))