AZE/FLU Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO)
研究概览
简要总结
Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.
详细描述
Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ARIA-based diagnosis of persistent moderate/severe AR (≥ 2 nasal symptoms suggestive of allergic rhinitis and positive skin prick tests to house dust mite (HDM) (HAL Allergy, Leiden, The Netherlands) at screening. Patients with additional seasonal pollen allergies may be included providing that they are included outside their individual pollen season, and with VAS score for total nasal symptoms of more than 5
- •VAS for TNS of more than 5, and rT5SS of more than 8 at both screening and randomization
- •Age > 18 and < 60 years
- •Eosinophilia of more than 5% in nasal secretions at screening
- •Nasal hyperreactivity (drop of PNIF >20 %) at randomization
- •Possibility to give reliable information and written informed consent
排除标准
- •Any evidence of clinically relevant acute or chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease at screening
- •History of allergic reaction to fluticasone propionate, azelastine hydrochloride or one of the excipients (e.g. benzalkonium chloride, phenylethyl alcohol, microcrystalline cellulose)
- •Patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts
- •Patients with tuberculosis, any type of untreated infection, or recent surgical operation or injury to the nose or mouth
- •Patients on prolonged use of decongestive nose sprays, suffering from so-called rhinitis medicamentosa
- •Patients using other nasal or oral medication affecting nasal function, like nasal corticosteroids, anticholinergics, cromoglycates, leukotriene antagonists, ACE inhibitors during the study or within the last 14 days before randomization; patients using oral corticosteroids during the last 30 days
- •Patients using cytochrome P450 inhibitors (e.g. ritonavir)
- •Nasal endoscopic evidence of rhinosinusitis with or without nasal polyposis (NP) or structural abnormalities such as clinically relevant septal deviation (septum reaching concha inferior or lateral nasal wall) or septal perforation at screening
- •Patients on immunotherapy (IT) for HDM or with history of IT for HDM
- •Patients with a psychiatric, addictive, or any disorder of which the investigators feel that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire
- •Patients being enrolled in other clinical trials within the last 3 months
- •Pregnancy or breastfeeding
- •Malignancies or severe comorbidity
- •Use of anticoagulation medication
研究组 & 干预措施
azelastine + fluticasone
azelastine 137 µg + fluticasone 50 µg combined applied twice daily one puff in each nostril duration: 4 weeks
干预措施: azelastine + fluticasone (Drug)
placebo
twice daily one puff in each nostril duration: 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO)
时间窗: 4 weeks after treatment
Change in expression of inflammatory mediators (Histamine / Substance P / interleukin 5 (IL-5) / EPO) at after 4 weeks of therapy with AZE/FP or placebo nasal spray. Unit of measurement: µg/ml
次要结局
- change in PNIF values upon CDA exposure(4 weeks treatment)