Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
2 other identifiers
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 5, 2021
October 1, 2021
1.9 years
May 24, 2016
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
change in symptom index on a visual analog scale nasal obstruction/running nose
3 months
change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)
3 months
change in nose-sinus related quality of life assessed with a visual analog scale (VAS)
3 months
change in the geometrics of the nose assessed by acoustic rhinometry
3 months
change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)
3 months
- +3 more secondary outcomes
Study Arms (1)
botox injection
EXPERIMENTAL* 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.
Interventions
botox injection under CT/MR navigation and with the navigation tool MultiGuide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St Olavs Hospital
Trondheim, Norway
Related Publications (1)
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.
PMID: 34633904RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Jacob Stovner, md prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
May 27, 2016
Study Start
October 1, 2016
Primary Completion
September 4, 2018
Study Completion
December 1, 2018
Last Updated
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share