DRKS00020994已完成2 期
Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
niversitätsklinikum Regensburg0 个研究点目标入组 20 人开始时间: 2020年3月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •o Age at least 18 years
- •o confirmed diagnosis of Osler's disease based on the Curacao criteria
- •o Written consent to the clinical trial
- •o Intellectual and linguistic ability to answer a questionnaire independently
- •o At least 2 TruBlue laser treatments in the area of the nasal mucosa
- •o Bleeding frequency more often than once a week and of which at least more than 5 minutes
排除标准
- •o Existing pregnancy (ß-HCG test is performed)
- •o Participation in another clinical trial
- •o Bronchial asthma or chronic obstructive pulmonary disease (COPD)
- •o Sinus bradycardia, Sick-sinus syndrome, second- or third-degree Sinuatrial block, AV block without pacemaker in history and eCG prior to clinical trial
- •o manifest heart failure, cardiogenic shock, angina pectoris in anamnesis
- •o Hypotension below 100/60 mmHg in the anamnesis and in pre-clinical trial examination
- •o Bradycardia (less than 60 beats per minute) in the ECG prior to the start of clinical trials
- •o Patients with severe peripheral circulatory disorders/diseases (e.g. severe forms of Raynaud's disease or Raynaud's syndrome) in the anamnesis
- •o Diabetes mellitus in the anamnesis
- •o Thyroid overfunction in anamnesis
- •o Pheochromocytoma in anamnesis
- •o Muscle weakness/ Myasthenia gravis in the anamnesis
- •o Patients with severe atopia or severe anaphylactic reactions to various allergens in the anamnesis
- •o Patients currently performing or planning hyposensitization
- •o in anamnesis hypersensitivity to beta-blockers or benzalkonium chloride
- •o concomitant use of oral calcium channel blockers (diltiazem/verapamil), antiarrhythmics (including amiodarone), digitalis and parasympatheticometics
- •o concomitant use with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine)
- •o concomitant use of systemic or opthalmological beta-blockers
- •o Taking oral anticoagulants
- •o Discontinuation of existing iron therapy with iron tablets or infusions or restart of iron therapy with iron tablets or infusions in the period one month before the start of the clinical trial until the completion of the clinical trial
- •o Surgical action in the area of the nose within the last 3 months prior to inclusion in the clinical trial and during the clinical trial in the sense of surgically preventing large feeding vessels or sewing of nasal septum films
研究者
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