Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis

July 22, 2021 updated by: Abdelrahman Ahmed Abdelalim, Benha University

Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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 .

  2. 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 .
  3. 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 .

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 13512
        • Benha University Hospital, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: BTX A Topical
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.
Other Names:
  • Topical
EXPERIMENTAL: Injection 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 .
Drug: BTX A Injection
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 .
Other Names:
  • Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rhinitis symptom severity
Time Frame: 2 months
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)
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
possible adverse effects
Time Frame: 2 months
epistaxis and nasal dryness (yes/no)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Chair: Naslshah G Kazeem, MD, benha faculty of medicine
  • Study Chair: Aya L Hassan, Resident, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

June 15, 2021

Study Completion (ACTUAL)

July 15, 2021

Study Registration Dates

First Submitted

September 26, 2020

First Submitted That Met QC Criteria

September 26, 2020

First Posted (ACTUAL)

October 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 3-11-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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