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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784262
• Other study ID #: 011015-01
• Secondary ID: 2015-004377-33
• Status: Completed
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Colorectal Neoplasms
• Ganglion Cysts
• Nasal Polyposis
• Nasal Polyps
• Nasopharyngeal Neoplasms
• Rhinitis

Intervention

Drug:
• botox injection Multiguide
botox injection under CT/MR navigation and with the navigation tool MultiGuide

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Jamtøy KA, Tronvik E, Bratbak DF, Crespi J, Stovner LJ, Aschehoug I, Thorstensen WM. OnabotulinumtoxinA injection towards the SPG for treating symptoms of refractory chronic rhinosinusitis with nasal polyposis: a pilot study. Acta Otolaryngol. 2021 Oct 11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	Registration of all adverse events sorted by probable relation to botox or surgery. Data collected from symptom diary, in addition to an open question at consultation and put into the Case Report Form (CRF) by physician or nurse.	from day 1 to 7 post surgery
Secondary	change in symptom index on a visual analog scale nasal obstruction/running nose		3 months
Secondary	change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)		3 months
Secondary	change in nose-sinus related quality of life assessed with a visual analog scale (VAS)		3 months
Secondary	change in the geometrics of the nose assessed by acoustic rhinometry		3 months
Secondary	change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)		3 months
Secondary	change in polyp mass assessed by magnetic resonance imaging (MRI)		3 months
Secondary	change in polyp mass assessed by computer tomography (CT)		3 months
Secondary	change in quality of life expressed by Patients' Global Impression of Change (PGIC)		3 months