I78.0 R04.0
Conditions
Interventions
Group 1: TruBlue laser therapy of the telangiectases in the area of the nasal mucosa in the nasal cavities (= standard therapy) + therapy with Timolol nasal spray 2 times daily a spray in each nostri
Sponsors
Universitätsklinikum Regensburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of epistaxis in HHT patients' disease as measured by the Epistaxis Severity Score (ESS) between TruBlue laser therapy with additional use of the placebo nasal spray (carrier solution of Timolol) and TruBlue laser therapy with additional use of a 0.5% Timolol nasal sprays. Measuring times are the study inclusion, after 3 months use of the nasal spray (placebo or verum) and after a further 3 months of use of another nasal spray (placebo or verum). | — |
Secondary
| Measure | Time frame |
|---|---|
| Compatibility and safety of the investigational product for the HHT patients suffering from epistaxis by regularly documenting pulse and blood pressure as well as documentation of AEs (adverse events). Subjective satisfaction of HHT patients suffering from epistaxis before, during and after taking the investigational drug on the basis of a numerical rating scale (NRS). blood values (haemoglobin/ferritin/transferrin) of participating HHT patients. Quality of life of Osler patients affected by epistaxis based on the EQ-5D questionnaire and the SFB questionnaire. | — |
Countries
Germany
Contacts
Public ContactKornelia Andorfer
UKR Regensburg
Outcome results
None listed