DRKS00020994
Completed
Phase 2
Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
niversitätsklinikum Regensburg0 sites20 target enrollmentStarted: March 10, 2020Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- niversitätsklinikum Regensburg
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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