NCT05474924

The Role of Budesonide Intrapolyp Injection in CRSwNP

The Role of Budesonide Intrapolyp Injection in Chronic Rhinosinusitis With Nasal Polyps. A Randomized Clinical Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Chronic rhinosinusitis with nasal polyps is a common nasal comorbidity with a wide range of symptoms that might cause severe distress and disabilities for patients. Many patients undergo repeated courses of systemic steroids and are exposed to various adverse effects. many cases finally revert to surgery. Budesonide was safely used as a nasal wash in cases of nasal polyps, our aim to determine If intrapolyp injection is a better method for delivering budesonide.

Detailed description

Chronic Rhinosinusitis with nasal polyps can be a severely debilitating disease, it's classically treated with steroids, and different methods of steroid delivery have been used for years. patients usually receive repeated courses of systemic steroids and experience many side effects. there have been trials of intrapolyp injection of steroids, especially triamcinolone acetate. these trials concluded that it's a safe intervention. Budesonide has been used as a nasal wash frequently in cases of nasal polyps, it also has been used safely as an intratympanic injection for cases of sudden hearing loss.. it's used as a systemic steroid in cases of inflammatory bowel diseases. The aim of our study is to test whether polyp injection is a more effective method of budesonide delivery and less dependent on subjective compliance rather than irrigation, and If it has comparable results with oral systemic steroids on polyps

Conditions

• CRS
• Polyp, Nasal

Interventions

Type	Name	Description
DRUG	Budesonide intrapolyp injection	intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids
DRUG	Budesonide nasal wash	Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.
DRUG	Prednisolone tablets	oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2022-07-26
• Last updated: 2022-07-26

Locations

1 site across 1 country: Egypt