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

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ClinicalTrials.gov Identifier: NCT02784262
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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 : October 2016
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: Botulinum toxin type A




Primary Outcome Measures :
  1. 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.


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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784262


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Lars Jacob Stovner, md prof Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02784262     History of Changes
Other Study ID Numbers: 011015-01
2015-004377-33 ( EudraCT Number )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Norwegian University of Science and Technology:
Botulinum Toxin Type A
Block
Sphenopalatine Ganglion

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Rhinitis
Chronic Disease
Ganglion Cysts
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms