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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: botox injection
Drug: botox injection Multiguide
botox injection under CT/MR navigation and with the navigation tool MultiGuide
Other Name: Botulinum toxin type A
- 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.
- change in symptom index on a visual analog scale nasal obstruction/running nose [ Time Frame: 3 months ]
- change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22) [ Time Frame: 3 months ]
- change in nose-sinus related quality of life assessed with a visual analog scale (VAS) [ Time Frame: 3 months ]
- change in the geometrics of the nose assessed by acoustic rhinometry [ Time Frame: 3 months ]
- change in air flow in the nose measured by peak nasal inspiratory flow (PNIF) [ Time Frame: 3 months ]
- change in polyp mass assessed by magnetic resonance imaging (MRI) [ Time Frame: 3 months ]
- change in polyp mass assessed by computer tomography (CT) [ Time Frame: 3 months ]
- change in quality of life expressed by Patients' Global Impression of Change (PGIC) [ Time Frame: 3 months ]
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
|St Olavs Hospital|
|Study Director:||Lars Jacob Stovner, md prof||Norwegian University of Science and Technology|