Phase 2
N=27
Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia
Hereditary Hemorrhagic Telangiectasia
Bottom Line
View on ClinicalTrials.gov: NCT04139018 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change in Assisted Epistaxis Severity Scale (aESS) Score From Baseline at 8 Week Follow-up — 2.32; 1.96 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Timolol Gel (Drug); Placebo Gel (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Assisted Epistaxis Severity Scale (aESS) Score From Baseline at 8 Week Follow-up |
2.32; 1.96 | — |
| SECONDARY Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale |
0; 1; 4; 3; 7; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Contraindications for systemic β adrenergic blocker administration
- Hypersensitivity to β adrenergic blockers
- Asthma or bronchospasm
- Congestive heart failure with LVEF 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
Data sourced from ClinicalTrials.gov (NCT04139018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.