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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004377-33 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botox injection | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botox injection Multiguide | Drug | botox injection under CT/MR navigation and with the navigation tool MultiGuide |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Jacob Stovner, md prof | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34633904 | Result | 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. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D009298 | Nasal Polyps |
| D012220 | Rhinitis |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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 |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |