NOSTRIL Trial 

Study Summary

Doxycycline, an inexpensive generic medication used by physicians for decades to treat bacterial infections, has displayed potent properties in blocking growth of new blood vessels inside and outside the body. The purpose of this study is to determine whether Doxycycline can be used to control nosebleeds (epistaxis) for patients with HHT.

Patients who are enrolled into the NOSTRIL Trial will be randomized to start with either the study medication (doxycycline) or a placebo. Subjects will take one treatment for 2 months followed by a 1-month washout period and then switch to the other treatment for another 2 months and a 1-month follow-up visit, which will mark the end their 6 month participation in the NOSTRIL Trial.

Your participation in this study is expected to last 6 months, with up to 6 clinic visits at UCLA for labs, questionnaires, and a physical exam.

How Can I Enroll in the NOSTRIL Trial?

HHT patients with moderate to severe nosebleeds, whether or not it has been treated, should contact Stephanie Gilbert, Study Coordinator, at [email protected] or 310-794-0376 to determine eligibility.

Principal Investigators

Justin McWilliams, MD – 310-267-8773

Gary Duckwiler, MD – 310-267-8599

Eligibility

• Positive HHT by the Curacao Criteria or a positive DNA test for HHT
• Between 18 – 80 years of age
• Not currently involved in any other experimental therapy for HHT
• Significant epistaxis (minimum of 3 bleeding episodes per week, total duration of nosebleeds at least 15 minutes per week
• Female patients with childbearing potential will require a negative pregnancy test at Day -1 of the trial and agree to use birth control during treatment and for 28 days following cessation of doxycycline
• Patients will also be excluded if they have used certain medications within 14 days prior to the study, including barbiturates, tegretol, dilantin, warfarin, isotretinoin, and a variety of other medications that are contra-indicated with doxycycline use

Study Procedure

• Patients who are enrolled into the NOSTRIL Trial will be randomized to start with either the study medication (doxycycline) or a placebo.
• Subjects will take one treatment for 2 months followed by a 1-month washout period and then switch to the other treatment for another 2 months
• 1-month follow-up visit, which will mark the end their 6 month participation in the NOSTRIL Trial.
• Participation in this study is expected to last 6 months, with up to 6 clinic visits at UCLA for labs, questionnaires, and a physical exam.
• The recruitment goal is 24 patients.
• The anticipated completion date for this clinical trial is July 1, 2019.

Are there costs associated with participating in this study?

• Everything is paid for by the study except the office visits which will be billed to the participant's insurance and there will be co-pays at each office visit.

Protocol ID:IRB#16-001827; UCLA IRB Approved; Approval Date: 5/3/2018 Through: 4/3/2019; Committee: Medical IRB 2