Botox injection in nerve bundle against nasal obstructio

Conditions: Chronic rhinosinusitis with nasal polyposis
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2015-004377-33-NO

Lead Sponsor: Department of Neuroscience, NT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Informed and written consent
2. Chronic rhinosinusitis with nasal polyposis defined in EPOS criteria
3. Person from 18 to 70 years old
4. Failed prophylactic treatments with local nasal steroids

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Heart or lung disease or any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
2. Psychiatric illness that hinders participation in the study
3. Known pregnancy or breast feeding
4. Inadequate use of contraceptives
5. Abuse of medications, narcotics or alcohol
6. Anomalies which hinder or impede the used method of injection
7. Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin
8. Allergy or any other hypersensitivity reactions against botulinum toxin type A, Botox or any of it's constituents or any other related medication
9. Treatment with medication that can interact with botulinum toxin type A
10. Suspicion of allergy to be one of the main causes of polyposis
11. Suspicion of Samters triade

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events;Secondary Objective: To evaluate the effect of the treatment;Primary end point(s): Adverse events related both to botox and the surgical procedure;Timepoint(s) of evaluation of this end point: For the follow-up period of three months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. changes in symptoms assessed by VAS <br>2. changes in quality of life evaluated using SNOT-22<br>3. changes in nasal geometry assessed by acoustic rhinometry<br>4. changes in nasal airflow measured with PNIF<br>5. changes in polyps assessed by MRI and CT;Timepoint(s) of evaluation of this end point: For the follow-up period of three months