NCT01408030

North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

North American Study of Epistaxis in HHT (NOSE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: James Gossage · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the NOSE Study is to carefully examine the efficacy and safety of 3 nasal sprays (bevacizumab, estriol, and tranexamic acid), compared to placebo, for the treatment of HHT related nosebleeds.

Detailed description

140 patients with moderate to severe epistaxis secondary to HHT will be randomized to receive one of four intranasal sprays for a period of 12 weeks and then followed for an additional 12 weeks off therapy. Enrollment will occur over a period of 18-36 months. The primary endpoint will be the frequency of epistaxis. Secondary endpoints will include duration of epistaxis, the Hoag Epistaxis Severity Score (ESS), a quality of life survey, satisfaction with treatment, hemoglobin and ferritin levels, transfusion requirements, and treatment failure. The sprays will be: saline spray (Placebo); estriol 0.1% in methylcellulose suspension (EST); tranexamic acid 10% in saline (TA), and bevacizumab 1% in saline (BEV). All sprays will be applied to the nasal mucosa by an identical spray bottle at a dose of 0.1 ml per nostril twice daily (total dose of 0.4 ml daily). Thus, the delivered doses will be: EST, 0.4 mg/day; TA, 40 mg/day; BEV, 4 mg/day.

Conditions

• Telangiectasia, Hereditary Hemorrhagic
• Epistaxis

Interventions

Type	Name	Description
DRUG	Sterile saline	0.9%, 0.1 ml spray in each nostril bid
DRUG	Bevacizumab	1% solution in saline, 0.1 ml spray in each nostril bid
DRUG	Estriol	0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
DRUG	Tranexamic Acid	10% solution in saline, 0.1 ml spray in each nostril bid

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2011-08-02
• Last updated: 2018-10-19
• Results posted: 2018-10-19

Locations

6 sites across 1 country: United States