Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Norwegian University of Science and Technology
Collaborator:
St. Olavs Hospital
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA