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

October 29, 2021 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 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.
from day 1 to 7 post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
change in symptom index on a visual analog scale nasal obstruction/running nose
Time Frame: 3 months
3 months
change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)
Time Frame: 3 months
3 months
change in nose-sinus related quality of life assessed with a visual analog scale (VAS)
Time Frame: 3 months
3 months
change in the geometrics of the nose assessed by acoustic rhinometry
Time Frame: 3 months
3 months
change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)
Time Frame: 3 months
3 months
change in polyp mass assessed by magnetic resonance imaging (MRI)
Time Frame: 3 months
3 months
change in polyp mass assessed by computer tomography (CT)
Time Frame: 3 months
3 months
change in quality of life expressed by Patients' Global Impression of Change (PGIC)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Lars Jacob Stovner, md prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

September 4, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 011015-01
  • 2015-004377-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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