Chronic Disease Clinical Trial
Official title:
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
Verified date | October 2021 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | December 2018 |
Est. primary completion date | September 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
Jamtøy 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 11 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | change in symptom index on a visual analog scale nasal obstruction/running nose | 3 months | ||
Secondary | change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22) | 3 months | ||
Secondary | change in nose-sinus related quality of life assessed with a visual analog scale (VAS) | 3 months | ||
Secondary | change in the geometrics of the nose assessed by acoustic rhinometry | 3 months | ||
Secondary | change in air flow in the nose measured by peak nasal inspiratory flow (PNIF) | 3 months | ||
Secondary | change in polyp mass assessed by magnetic resonance imaging (MRI) | 3 months | ||
Secondary | change in polyp mass assessed by computer tomography (CT) | 3 months | ||
Secondary | change in quality of life expressed by Patients' Global Impression of Change (PGIC) | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03153644 -
Improving Contraceptive Care for Women With Medical Conditions
|
||
Recruiting |
NCT06058754 -
Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial)
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05558085 -
Biomarker Cost-Benefit Analysis of EFNEP
|
N/A | |
Completed |
NCT04037436 -
Functional Exercise and Nutrition Education Program for Older Adults
|
N/A | |
Not yet recruiting |
NCT05622422 -
A Chronic Disease Self Care Management Pilot Study
|
N/A | |
Not yet recruiting |
NCT06016101 -
Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
|
||
Not yet recruiting |
NCT04954209 -
Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs
|
||
Not yet recruiting |
NCT04090593 -
Chronic Disease Mobile Educational Experience
|
N/A | |
Not yet recruiting |
NCT03628963 -
Optimizing Patient Usability Experience for Chronic Care
|
N/A | |
Completed |
NCT02390570 -
Incorporating Patient Capacity Into the Clinical Landscape
|
N/A | |
Completed |
NCT02072941 -
Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
|
N/A | |
Completed |
NCT02017262 -
Group Self-Management of Depression and Medical Illness
|
N/A | |
Terminated |
NCT02115971 -
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
|
N/A | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Completed |
NCT02292940 -
Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions
|
||
Completed |
NCT02307929 -
Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA
|
N/A | |
Completed |
NCT01458184 -
Study of PhoneCare System to Treat Patients With Chronic Diseases
|
N/A | |
Completed |
NCT00333710 -
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
|
N/A | |
Completed |
NCT00380536 -
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
|
N/A |