EUCTR2014-001088-11-BE进行中（未招募）不适用
Academic study on the effects of MP 29-02 nasal spray on inflammatory mediators in allergic rhinitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MEDA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with an ARIA-based diagnosis of persistent moderate/severe AR (= 2 nasal symptoms suggestive of allergic rhinitis and positive skin prick tests to 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
- •2.VAS for TNS of more than 5, and rT5SS of more than 8 at both screening and randomization
- •3.Age > 18 and < 60 years
- •4.Eosinophilia of more than 5% in nasal secretions at screening
- •5.Nasal hyperreactivity (drop of PNIF >20 %) at randomization
- •6.Possibility to give reliable information and written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any evidence of clinically relevant acute or chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease at screening
- •2.History of allergic reaction to fluticasone propionate, azelastine hydrochloride or one of the excipients (e.g. benzalkonium chloride, phenylethyl alcohol, microcrystalline cellulose)
- •3.Patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts
- •4.Patients with tuberculosis, any type of untreated infection, or recent surgical operation or injury to the nose or mouth
- •5.Patients with moderate persistent to severe persistent asthma according to GINA criteria (9)
- •6.Patients on prolonged use of decongestive nose sprays, suffering from so-called rhinitis medicamentosa
- •7.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
- •8.Patients using cytochrome P450 3A4 inhibitors (e.g. ritonavir)
- •9.Nasal endoscopic evidence of rhinosinusitis w/wo NP or structural abnormalities such as clinically relevant septal deviation (septum reaching concha inferior or lateral nasal wall) or septal perforation at screening
- •10.Patients on immunotherapy (IT) for HDM or with history of IT for HDM
- •11.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
- •12.Patients being enrolled in other clinical trials within the last 3 months
- •13.Pregnancy or breastfeeding
- •14.Malignancies or severe comorbidity
- •15.Smoking
- •16.Use of anticoagulation medication
研究者
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