EUCTR2015-005155-27-SI进行中（未招募）1 期
Comparison of the efficacy and safety of the fixed-dose combination of xylometazoline and dexpanthenol in SeptaNazal® and xylometazoline in nasal congestion in patients after surgery in the nose and paranasal cavity and in patients with acute rhinitis – SeptaNazal DOUBLE clinical study.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 194
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
- •Patients after nasal surgery or nasal cavities surgery (Group 1):
- •Aged 18-60 years
- •Recent nasal surgery or nasal cavities surgery (patients with chronic rinosinusitis with nasal polyps (CRSwNP) and patients with chronic rinosinusitis without nasal polyps (CRSsNP)
- •Can carry out intranasal administration of the investigational medicinal product
- •Signed Informed consent form
- •Patients with acute rhinitis (Group 2):
- •Aged 18-60 years
- •Diagnosed with acute rhinitis
- •Can carry out intranasal administration of the investigational medicinal product
- •Signed Informed consent form
- •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 270
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to the active substances or to any of the excipients
- •Dry nasal inflammation (rhinitis sicca)
- •History of transsfenoidal hypophysectomy or other surgical procedures in which the dura mater was exposed
- •Patients who are treated with drugs for local or systemic treatment of influenza, and sympathomimetic agents, which contain a medicament for the treatment for cough and/or cold
- •Pregnancy or breast-feeding
- •Patients with asthma who require treatment with corticosteroids
- •Rhinitis medicamentosa
- •Chronic rhinitis
- •Patients treated with monoamine oxidase inhibitors (MAOIs) or other drugs that may raise blood pressure
- •Patients with increased intraocular pressure, in particular with angle-closure glaucoma
- •Patients with pheochromocytom
- •Nose injury less than 3 months prior the first visit
- •Current treatment with nasal decongestants
- •Respiratory tract infection within 2 weeks prior the first visit (including otitis media), who required treatment with antibiotics
- •Current smoker or ex-smoker less than 6 months prior the first visit
- •Participation in another clinical trial within thirty days prior the first visit
研究者
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