Chronic Disease, Nasal Polyposis, Rhinitis
Conditions
Keywords
Botulinum Toxin Type A, Block, Sphenopalatine Ganglion
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.
Interventions
DRUGbotox injection Multiguide
botox injection under CT/MR navigation and with the navigation tool MultiGuide
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 symptom index on a visual analog scale nasal obstruction/running nose | 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 |
| change in air flow in the nose measured by peak nasal inspiratory flow (PNIF) | 3 months |
Countries
Norway
Outcome results
None listed