Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - (TEMPO)

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT02484716
• Date of registration: 17/06/2015
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - (TEMPO) TEMPO
• Scientific title: Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - Randomized Trial Versus Placebo
• Date of first enrolment: June 2015
• Target sample size: 58
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02484716
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Patients who give voluntary, informed consent and sign a consent form.

- Patients affiliated with the French universal health care system

- Patients treated for HHT, that has been confirmed clinically (presence of at least 3
Curaçao criteria) and/or by molecular biology.

- Patients who present epistaxis averaging over 20 minutes in the three months before
inclusion, justified by completed epistaxis tally sheets.

Exclusion Criteria:

- Pregnant women or women who could become pregnant during the study, or during
lactation

- Patients not affiliated with the French universal health care system

- Patients who are protected adults according to the terms of the law (French public
health laws).

- Refusal to give consent.

- Patients whose HHT diagnosis has not be confirmed clinically and/or by molecular
biology.

- Participation in another therapeutic trial which could interfere with the present
trial (investigator jugement).

- Bronchial asthma, presence or history of severe chronic obstructive pulmonary disease

- Cardiac history : cardiac failure or cardiogenic shock. Atrioventricular block (second
or third degrees) not controlled with pace-maker or sinus disease (included sinoatrial
block) confirmed by ECG less than one year. Ongoing treatment by calcium antagonists
(bépridil, diltiazem, verapamil) or antiarrhytmics (propafénone, quinidine,
hydroquinidine, disopyramide) or clonidine or lidocaîne. Ongoing beta-blocker
treatment.

- Bradycardia (<50 pulse per minute)

- Hypotension (PAS < 90 Hg mm)

- Angina

- Not controlled Pheochromocytoma

- Severe peripheral circulatory disturbances (Raynaud disease)

- Hypersensitivity to the active substance, any of the excipients or other beta-blocking
agents

- Ongoing treatment by floctafénine or sultopride or amiodarone

- Patients who do not complete epistaxis grids for three months before treatment

- Patients who present epistaxis averaging below 20 minutes in the three months before
inclusion



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osler Rendu Disease

Telangiectasia, Hereditary Hemorrhagic

Intervention(s)

Drug: Placebo nasal spray

Drug: Timolol nasal spray

Primary Outcome(s)

Efficacy of timolol nasal spray on duration of nosebleeds for 3 months after the end of the treatment. [Time Frame: Day 0 (inclusion) ; up to 4 months]

Secondary Outcome(s)

Efficacy on clinical criteria : epistaxis frequency . [Time Frame: Day 0 (inclusion) ; up to 4 months]

Efficacy of timolol nasal spray on duration of nosebleeds for 6 months after the end of the treatment. [Time Frame: Day 0 (inclusion) ; up to 7 months]

Efficacy on clinical criteria : quality of life (SF36). [Time Frame: Day 0 (inclusion) ; up to 4 months]

Efficacy on clinical criteria : biological parameters (hemoglobin and ferritin level). [Time Frame: Day 0 (inclusion) ; up to 4 months]

Tolerance of timolol nasal spray in patients with HHT-related epistaxis [Time Frame: up to 7 months]

Secondary ID(s)

2015-000385-55

69HCL15_0063

Source(s) of Monetary Support

Please refer to primary and secondary sponsors