EUCTR2019-001717-17-DE进行中（未招募）1 期
A multi-centre, randomised, placebo-controlled, double-blind parallel-group trial to assess the efficacy and safety of SIA capsules in subjects with acute rhinosinusitis.
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
- 456
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.Voluntary written informed consent for trial participation and handling of personal data in concurrence with the European General Data Protection Declaration (GDPR) has been obtained prior to performance of any trial specific procedures or assessments
- •2.Male or female outpatient adults aged =18 years
- •3.Clinically evident diagnosis of acute rhinosinusitis
- •4.Severity of the five main rhinosinusitis symptoms (MSS) characterised as follows based on the investigator’s ratings at Visit 1 (screening):
- •-Sum score MSSINV =8 points and =12 points
- •-Individual score for facial pain/ pressure =1 (mild) and =2 (moderate)
- •5.Presence of rhinosinusitis symptoms for 3 days or less (i.e. symptoms started =3 days before Visit 1)
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •1.Acute symptoms of a known allergic rhinitis
- •2.Signs or symptoms of fulminant bacterial sinusitis (e.g. fever >38.5°C), orbital complications, severe unilateral frontal headache or toothache)
- •3.History of chronic rhinosinusitis with exacerbations within 6 months prior to Visit 1
- •4.History of polyposis nasi
- •5.History of odontogenic sinusitis
- •6.History of chronic nasal congestion (e.g. due to known anatomical deviations of the nasal septum etc.)
- •7.Paranasal sinus surgery up to two years prior to Visit 1
- •8.History of cystic fibrosis
- •9.History of asthma with exacerbations (asthma attacks) within the past 30 days prior to Visit 1
- •10.Known hypersensitivity to trial medication or excipients
- •11.Underlying diseases leading to significant immune deficiency
- •12.Inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct at the time of inclusion or within the last 6 months before Visit 1.
- •13.History of severe somatopathic, neurological and/ or psychiatric diseases
- •14.Malignant growth (actual, condition after carcinoma less than 5 years without relapse)
- •15.Only for female subjects of childbearing potential: Woman who is pregnant or breast feeding, or without highly effective contraception (failure rate less than 1%)
- •16.Treatment with systemic antibiotics, or with nasal or systemic corticosteroids within the last 4 weeks prior to Visit 1 (excluding inhaled corticosteroids for mild to moderate persistent asthma)
- •17.Treatment with mucolytics/ secretolytics, antihistamines, or alternative medicine preparations or drugs with immunomodulating properties within the last 7 days prior to Visit 1
- •18.Use of paracetamol, decongestant preparations, systemic analgesics (including systemic non-steroidal anti-inflammatory drugs [NSAIDs]), the day of Visit 1 (before randomisation)
- •19.History or presence of drug or alcohol abuse
- •20.Parallel participation in another clinical trial with an investigational product, participation in a clinical trial within less than 6 weeks prior to Visit 1
- •21.Known to be, or suspected of being unable to comply with the trial protocol (e.g., no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
- •22.Legal incapacity and/ or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial
- •23.Subject in custody by juridical or official order
- •24.Subject who has difficulties in understanding the language (German) in which the subject information (informed consent form) is given
- •25.Subjects who are members of the staff of the trial centre, staff of the sponsor or the clinical research organisation (CRO), the investigator him-/ herself or close relatives of the investigator
研究者
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