Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - (TEMPO)
Status:
Completed
Trial end date:
2018-01-29
Target enrollment:
Participant gender:
Summary
Timolol is a nonselective β-blocker commonly used in the treatment of glaucoma. Recently it
has been used topically for the treatment of superficial hemangiomas. Because of its
potential mechanism of action, it is possible that timolol could also be useful for the
treatment of epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT). Moreover a case was
reported in 2012 showing an improvement of nosebleeds with the use of topical nasal timolol.
The aim of the study is to evaluate timolol nasal spray efficacy in HHT.
The main objective of this trial is to evaluate, 3 months after the end of the treatment, the
efficacy on the duration of nosebleeds of a 4 weeks timolol intranasal treatment in HHT
patients with nosebleeds (>20 min/month). Secondary objectives are to evaluate the tolerance,
the efficacy at 6 months after the end of the treatment, and the efficacy on anemia and on
clinical parameters (nosebleeds, quality of life and blood transfusions).
This is a prospective double blind phase II study, randomized versus placebo using an
allocation ratio of 1:1. A total of 58 patients will be included. The product (solution with
timolol at 0.5% or placebo) is self-administered by the patient with a posology of one spray
(50 µL) in each nostril twice a day for 28 consecutive days.