Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change of Sino-Nasal Outcome Test (SNOT) score from baseline
研究概览
简要总结
Proof-of-concept study with a novel nasal spray in chronic rhinitis or chronic sinusitis. The study will involve 25 patients completing the study for a per protocol analysis.
详细描述
Visit 1 (Day 0): Screening visit. Assessment of outcome measures
Visit 2 (Day 7): Enrollment visit after a 1-week wash-out period. Enrolled to the Study are only patients who show a severe enough and stable disease (SNOT score >20 and change of SNOT score <15% compared to Visit 1, respectively).
Visit 3 (Day 21): Assessment of outcome measures after 2-week treatment phase
Visit 4 (Day 49): Follow-up visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinically diagnosed chronic allergic rhinitis or chronic sinusitis with no or a mild status of nasal polyp activity
- •Disease lasting 12 weeks or longer
- •Patients with moderate or severe symptoms (SNOT-22 score >20)
- •Male or female at least 18 years old
- •Females in childbearing age are requested to make a pregnancy test and to confirm in writing to take contraceptive measures until Follow-up Visit (Day 49).
- •Patient understands German
排除标准
- •Severely purulent forms of sinusitis
- •History of medication during the last four weeks
- •not allowed: antibiotics, systemic or topical steroids
- •allowed: nasal saline spray or irrigation, analgesics, decongestants, antihistamines
- •Patient has a status of moderate or severe polyp activity in the nose
- •Patient had sinus surgery in the past 6 months
- •Patient needs O2 substitution
- •Patient has cystic fibrosis
- •Patient has primary ciliary dyskinesia
- •Patient is demented or otherwise incapable of judgement
研究组 & 干预措施
Jantar-1 (JT-1), 7% (w/w) aqueous solution
Dosing regimen: ad libitum between at least 2 doses, in the morning and in the evening, and at most 10 doses per day. A dose corresponds to two strokes of 100ul each per nostril.
干预措施: JT-1 (Drug)
结局指标
主要结局
Change of Sino-Nasal Outcome Test (SNOT) score from baseline
时间窗: Baseline (enrollment visit) and after 2-week treatment phase
Questionnaire of 22 questions on the subjective clinical symptoms of chronic rhinitis and chronic sinusitis, score between 0 (no symptoms) and 120 (worst possible disease)
次要结局
- Change of Peak Nasal Inspiratory Flow (PNIF) from baseline(Baseline (enrollment visit) and after 2-week treatment phase)
- Change of Visual Analog Scale (VAS) of Headache Intensity(Baseline (enrollment visit) and after 2-week treatment phase)
- Change of Smell Diskettes Olfactory Test from baseline(Baseline (enrollment visit) and after 2-week treatment phase)
- Change of Visual Analog Scale (VAS) of Nasal Discomfort(Baseline (enrollment visit) and after 2-week treatment phase)