Clinical trial NCT02784262: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
Official title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Disease
Nasal Polyposis
Rhinitis
Keywords: Botulinum Toxin Type A
Block
Sphenopalatine Ganglion
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2016-05-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: adverse events
timeFrame: from day 1 to 7 post surgery
Secondary outcomes:
measure: change in symptom index on a visual analog scale nasal obstruction/running nose
timeFrame: 3 months
measure: change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)
timeFrame: 3 months
measure: change in nose-sinus related quality of life assessed with a visual analog scale (VAS)
timeFrame: 3 months
measure: change in the geometrics of the nose assessed by acoustic rhinometry
timeFrame: 3 months
measure: change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)
timeFrame: 3 months
measure: change in polyp mass assessed by magnetic resonance imaging (MRI)
timeFrame: 3 months
measure: change in polyp mass assessed by computer tomography (CT)
timeFrame: 3 months
measure: change in quality of life expressed by Patients' Global Impression of Change (PGIC)
timeFrame: 3 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lars Jacob Stovner, md prof
role: STUDY_DIRECTOR
References:
citation: Jamtoy 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;141(10):934-940. doi: 10.1080/00016489.2021.1982146. Epub 2021 Oct 11.