Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis

Norwegian University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Nasal Polyposis; Chronic Disease; Rhinitis

Treatments: Drug: botox injection Multiguide

Study type: Interventional

Funder types: Other

Identifiers

NCT02784262

2015-004377-33 (EudraCT Number)

011015-01

Details and patient eligibility

About

Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many patients return to the health care providers with persistent symptoms after repeated medical and surgical treatment. Patients have usually tried several different types of treatments, ranging from less invasive procedures to extensive surgical treatment. The surgical treatment is often repeated several times. The most common surgical treatment is functional endoscopic sinus surgery, another established procedure is Vidian neurectomy.

The main object of this pilot study is to investigate the safety of onabotulinumtoxin A towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data will also be collected to provide indication on whether future placebo-controlled studies should be performed.

Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling, secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9 months and will not lead to damage of the nerve.

This study opens up for improved treatment with less complications.

Enrollment: 11 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• written informed consent
• chronic rhinosinusitis with nose polyps (CRSwNP) according to European position paper on rhinosinusitis and nasal polyps (EPOS) criteria
• no satisfactory effect of medicinal or surgical treatment

Exclusion criteria

• systemic or local disease or condition that may result in a higher risk for complications
• psychiatric disorder that is indicates against the treatment
• pregnancy, breastfeeding, fertile female not using contraception
• abuse of drugs, narcotics or alcohol
• hypersensitivity against marcain, lidocain, xylocain, or adrenalin, and similar drugs
• anatomical conditions that hinder injection
• known sensitivity for botulinum toxin type A or for adjuvant substances
• treatment with drugs that interact with botulinum toxin type A:
• suspicion of polyps caused by an allergy
• suspicion of Samters triade

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

botox injection

Experimental group

Description:

* Preoperative medication: Paracetamol 1,5g oral, diclofenac 50mg (evt ibuprofen 600mg) oral and/or diazepam 5-10 mg oral. * Skin and tissue inside the projected injection canal will be infiltrated with 5-10ml Marcain-Adrenalin (5mg/ml + 5microg/ml) for local anaesthesia. * Localization will be confirmed with help of navigation before the medication will be given. Intravascular injection will be prevented by control of aspiration.

Treatment:

Drug: botox injection Multiguide