Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale for Major Nasal Symptoms
研究概览
简要总结
Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms: rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in VAS for major nasal symptom on week 4.
(Estimated placebo effect is 25%.)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic rhinitis patients with at least 2 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
- •idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
- •Age > 18 and < 65 years.
- •Written informed consent.
- •Willingness to adhere to visit schedules.
- •Adequate contraceptive precautions in female patients with childbearing potential.
排除标准
- •Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. *
- •Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
- •Patients with local allergic rhinitis (LAR) or entopy.
- •Systemic steroid treatment less than 4 weeks before the inclusion in the study, nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
- •Inability of the patient to stop taking medication affecting nasal function like ß-blockers.
- •History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication.
- •Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion.
- •Pregnancy or lactation. **
- •Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
- •Enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition.
- •Contra-indications for the use of local anesthesia (cocaine 5%).
- •Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
- •Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.
研究组 & 干预措施
0.1mM
干预措施: Capsaicin (Drug)
0.01mM
干预措施: Capsaicin (Drug)
0.001mM
干预措施: Capsaicin (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in Visual Analogue Scale for Major Nasal Symptoms
时间窗: Baseline and week 4
patients score their main nasal complaints from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment
次要结局
- Change in Visual Analogue Scale for Individual Nasal Symptoms(Baseline, week 4)
- Change of Nasal Hyperreactivity in All Treatment Modalities.(baseline, week 4)
- Therapeutic Response in All Treatment Regimes(week 4)
- Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities(week 4, 12 and 26)
- Number of Adverse Events in All Treatment Groups(week 4)