Status:
COMPLETED
Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia
Lead Sponsor:
Washington University School of Medicine
Conditions:
Hereditary Hemorrhagic Telangiectasia
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study is a double-blinded, randomized controlled trial to evaluate the efficacy of an intranasal topical timolol gel in the care for epistaxis in adults with hereditary hemorrhagic telangiectasia...
Detailed Description
This study is a double-blinded, placebo-controlled, 8-week randomized clinical trial investigating the efficacy of timolol gel in the management of epistaxis in adults with HHT. The Specific Aims are...
Eligibility Criteria
Inclusion
- Adults ages 20 and older
- Confirmed clinical (meeting at least 3 of the 4 Curaçao Criteria) or genetic diagnosis of HHT
- Epistaxis Severity Score (ESS) ≥ 4 and 2 or more nosebleeds per week with a cumulative nosebleed duration of at least 5 minutes per week
- Stable nasal hygiene and medical regimen for preceding 1 month
- Stable epistaxis pattern over the preceding 3 months
Exclusion
- Contraindications for systemic β adrenergic blocker administration
- Hypersensitivity to β adrenergic blockers
- Asthma or bronchospasm
- Congestive heart failure with LVEF \<40%
- Hereditary pulmonary arterial hypertension
- Baseline bradycardia (HR \<55 beats per minute)
- Sick Sinus Syndrome
- 2nd or 3rd degree heart block, left or right bundle branch block, or bifasicular block
- Uncontrolled diabetes mellitus (most recent HbA1c \>9%) or diabetic ketoacidosis within last 6 months
- Hypotension (systolic blood pressure \< 90)
- Known hypersensitivity to timolol
- Severe peripheral circulatory disturbances (Raynaud phenomenon)
- Known intermediate or poor metabolizer variant of the liver enzyme CYP2D6
- Current use of any of the following known strong CYP2D6 inhibitors: fluoxetine (Prozac), paroxetine (Paxil), bupropion (Welbutrin), quinidine, quinine, ritonavir (Norvir), and terbinafine (Lamisil)
- Current use of the following other drugs known to pharmacodynamically interact with timolol: diltiazem, verapamil, digoxin, digitalis, propafenone, disopyramide, clonidine, flecainide, or lidocaine
- Patients currently treated or who plan to initiate treatment with β-blockers
- Use of any anti-angiogenic medication in the last month prior to recruitment, including bevacizumab, pazopanib, thalidomide, or lenalidomide
- Illicit drug use, except marijuana
- Known pheochromocytoma
- Use of anticoagulants, antiplatelet, or fibrinolytic therapies within the last month prior to recruitment, except for low-dose (81 mg or less) of aspirin
- Pregnancy or planned pregnancy in the next 6 months or currently breastfeeding
- Inability to read or understand English
- Inability to complete 8 weeks of therapy for any reason
Key Trial Info
Start Date :
October 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04139018
Start Date
October 20 2019
End Date
May 20 2020
Last Update
August 24 2021
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110