Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis
Primary Purpose
Chronic Rhinosinusitis (Diagnosis)
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
BTX A Topical
BTX A Injection
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis) focused on measuring Chronic rhinosinustitis, Botulium Toxin A
Eligibility Criteria
Inclusion Criteria:
- Patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study.
Exclusion Criteria:
- Patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps).
- Having systemic illness such as DM, HTN, Malignancy or Tuberculosis.
- History of nasal surgery such as turbinate reduction surgery orseptoplasty.
- Acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge
- Radiological finding of nasal tumors or fungal sinusitis.
- Any accompanying disease such as glaucoma or prostate hypertrophy or myasthenia that might be aggravated by anticholinergic therapy .
- use of systemic or local corticosteroid less than 1 month prior the study.
- Pregnancy or lactation.
- History of allergy to botox or local anesthetic agents.
Sites / Locations
- Benha University Hospital, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Topical group
Injection group
Arm Description
Topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
Outcomes
Primary Outcome Measures
the rhinitis symptom severity
the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe)
Secondary Outcome Measures
possible adverse effects
epistaxis and nasal dryness (yes/no)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04572516
Brief Title
Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis
Official Title
Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients
Detailed Description
A prospective comparative study will be carried out on 30 participant of both sex at Otorhinolaryngology Department, Benha University Hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing.
The patients will be divided randomly into two groups:
Group A (topical group) : 15 patients
Group B (injected group) : 15 patients
All patients will be subjected to:
Full clinical evaluation:
A) Full history taking B) Clinical examination by
anterior rhinoscopy to evaluate the nasal cavity to exclude purulent discharge , nasal polyps or anterior septal deviation.
nasal endoscopy to exclude nasal infection signs ,nasal polyps ,the posterior septal deviation or adenoid .
C) Investigations:CT nose and paranasal sinuses coronal cuts to exclude fungal sinusitis, nasal polyps or other structural abnormalities e.g; posterior septal deviation, conchae bullosa or any other nasal pathology .
Intervention :
BTX -A available in the Egyptian market in the form of powder vial (Allergan) containing 100 Units, will be dissolved in 10 cc saline to obtain clear colorless solution in which each 1cc contain 10 Units.
In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
In group B (injected group), 20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
Follow Up Follow up visits will be at 1,2,4,6,8 weeks, patients will be assessed and questionnaired about severity of the symptoms and possible adverse effects including epistaxis and nasal dryness .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)
Keywords
Chronic rhinosinustitis, Botulium Toxin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical group
Arm Type
Experimental
Arm Description
Topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
Arm Title
Injection group
Arm Type
Experimental
Arm Description
20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
Intervention Type
Drug
Intervention Name(s)
BTX A Topical
Other Intervention Name(s)
Topical
Intervention Description
In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
Intervention Type
Drug
Intervention Name(s)
BTX A Injection
Other Intervention Name(s)
Injection
Intervention Description
In group B (injected group), 20 units of BTX_A(2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
Primary Outcome Measure Information:
Title
the rhinitis symptom severity
Description
the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
possible adverse effects
Description
epistaxis and nasal dryness (yes/no)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study.
Exclusion Criteria:
Patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps).
Having systemic illness such as DM, HTN, Malignancy or Tuberculosis.
History of nasal surgery such as turbinate reduction surgery orseptoplasty.
Acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge
Radiological finding of nasal tumors or fungal sinusitis.
Any accompanying disease such as glaucoma or prostate hypertrophy or myasthenia that might be aggravated by anticholinergic therapy .
use of systemic or local corticosteroid less than 1 month prior the study.
Pregnancy or lactation.
History of allergy to botox or local anesthetic agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrahman A Abdelalim, MD
Organizational Affiliation
Benha Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed A Elsayed, MD
Organizational Affiliation
Benha Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Naslshah G Kazeem, MD
Organizational Affiliation
Benha Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aya L Hassan, Resident
Organizational Affiliation
Benha University
Official's Role
Study Chair
Facility Information:
Facility Name
Benha University Hospital, Faculty of Medicine
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13512
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28681969
Citation
Zhang EZ, Tan S, Loh I. Botolinum toxin in rhinitis: Literature review and posterior nasal injection in allergic rhinitis. Laryngoscope. 2017 Nov;127(11):2447-2454. doi: 10.1002/lary.26616. Epub 2017 Jul 6.
Results Reference
background
PubMed Identifier
16935174
Citation
Ozcan C, Vayisoglu Y, Dogu O, Gorur K. The effect of intranasal injection of botulinum toxin A on the symptoms of vasomotor rhinitis. Am J Otolaryngol. 2006 Sep-Oct;27(5):314-8. doi: 10.1016/j.amjoto.2006.01.008.
Results Reference
background
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Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis
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