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

NCT ID: NCT02784262

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Disease Nasal Polyposis Rhinitis

Keywords

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Botulinum Toxin Type A Block Sphenopalatine Ganglion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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botox injection

* 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.

Group Type EXPERIMENTAL

botox injection Multiguide

Intervention Type DRUG

botox injection under CT/MR navigation and with the navigation tool MultiGuide

Interventions

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botox injection Multiguide

botox injection under CT/MR navigation and with the navigation tool MultiGuide

Intervention Type DRUG

Other Intervention Names

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Botulinum toxin type A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Jacob Stovner, md prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 34633904 (View on PubMed)

Other Identifiers

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2015-004377-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

011015-01

Identifier Type: -

Identifier Source: org_study_id