NCT04572516

Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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 .

Conditions

• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
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.
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 .

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-06-15
• Completion: 2021-07-15
• First posted: 2020-10-01
• Last updated: 2021-07-23

Locations

1 site across 1 country: Egypt