Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis

Benha University

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: BTX A Injection; Drug: BTX A Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT04572516

MS 3-11-2019

Details and patient eligibility

About

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

Full 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 .

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Topical group

Experimental group

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.

Treatment:

Drug: BTX A Topical

Injection group

Experimental group

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 .

Treatment:

Drug: BTX A Injection