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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02784262

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease Nasal Polyposis Rhinitis	Drug: botox injection Multiguide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Sep 4, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: botox injection Multiguide botox injection under CT/MR navigation and with the navigation tool MultiGuide Other Names: Botulinum toxin type A

Arm

Intervention/Treatment

Experimental: 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.

Drug: botox injection Multiguide

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

Other Names:

Botulinum toxin type A

Outcome Measures

Primary Outcome Measures

adverse events [from day 1 to 7 post surgery]
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.

Secondary Outcome Measures

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]
change in polyp mass assessed by magnetic resonance imaging (MRI) [3 months]
change in polyp mass assessed by computer tomography (CT) [3 months]
change in quality of life expressed by Patients' Global Impression of Change (PGIC) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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