Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01408030

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

Epistaxis Clinical Trial

Official title:
North American Study of Epistaxis in HHT (NOSE)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01408030
Study type Interventional
Source Augusta University
Contact
Status Completed
Phase Phase 2
Start date August 2011
Completion date September 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT05334017 - Xylometazoline and Cocaine for Nasal Vasoconstriction Phase 4
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Recruiting NCT01886768 - Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy N/A
Recruiting NCT00390663 - A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in Children Phase 4
Suspended NCT04054687 - Intranasal TXA for Anterior Epistaxis in the Emergency Department Phase 2
Completed NCT02285634 - The Effect of Intranasal Vasoconstrictor Medications on Hemodynamic Parameters: A Randomized Double-blind, Placebo-controlled Trial. N/A
Completed NCT01485224 - Efficacy of Thalidomide in the Treatment of Hereditary Hemorrhagic Telangiectasia Phase 2
Completed NCT00793117 - The Effect of Packing in Post Operative Management of FESS Phase 4
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Recruiting NCT03850964 - Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) Phase 2/Phase 3
Recruiting NCT05281952 - Medico-economic Evaluation of Management Strategies for Severe Epistaxis N/A
Completed NCT03360045 - Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis Phase 4
Completed NCT04279288 - The Roles of Hilotherapy in the Management of Epistaxis and Nasal Fractures N/A
Completed NCT03912051 - Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting N/A
Not yet recruiting NCT02677467 - Correlation Between Epistaxis and Cardiovascular Disease N/A
Completed NCT01314274 - Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Phase 2
Terminated NCT01051427 - Control of Epistaxis With Surgiflo N/A
Completed NCT00863356 - Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis N/A
Recruiting NCT05269849 - Sirolimus for Nosebleeds in HHT Phase 2
Not yet recruiting NCT05343650 - NOVAPAK Nasal Packing in Shellfish Allergic Patients Phase 4