Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis

NCT04572516 | Completed Phase 3

• 1 other identifier: MS 3-11-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Chronic rhinosinustitis; Botulium Toxin A

Outcome Measures

Primary Outcomes (1)

• 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)

  2 months

Secondary Outcomes (1)

• possible adverse effects

  2 months

Study Arms (2)

Topical group

EXPERIMENTAL

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

Injection group

EXPERIMENTAL

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

Interventions

BTX A Topical DRUG

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.

Also known as: Topical

Topical group

BTX A Injection DRUG

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 .

Also known as: Injection

Injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital, Faculty of Medicine

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (2)

• 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.

  PMID: 28681969 BACKGROUND

• 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.

  PMID: 16935174 BACKGROUND

MeSH Terms

Conditions

Disease

Interventions

Injections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Abdelrahman A Abdelalim, MD

  Benha University

  PRINCIPAL INVESTIGATOR

• Mohamed A Elsayed, MD

  Benha University

  STUDY CHAIR

• Naslshah G Kazeem, MD

  Benha University

  STUDY CHAIR

• Aya L Hassan, Resident

  Benha University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Lecturer

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 1, 2020
• Study Start: May 1, 2020
• Primary Completion: June 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)