Clinical trial NCT05474924: The Role of Budesonide Intrapolyp Injection in CRSwNP
Official title: The Role of Budesonide Intrapolyp Injection in Chronic Rhinosinusitis With Nasal Polyps. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: CRS
Polyp, Nasal
Keywords: budesonide
CRSwNP
chronic Rhinosinusitis
Nasal polyps
Intrapolyp injection
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* All patients with type 2 CRSwNP -indicated by elevated serum IgE \& high absolute Eosinophilia- with nasal polyps whose
* ages between 18 and 60 years old
* who don't have any contraindications of systemic steroids such as glaucoma, peptic ulcer, acute psychosis, chronic infections, severe osteoporosis, severe hypertension, uncontrolled diabetes mellitus, history of thromboembolic events

Exclusion Criteria:

* cystic fibrosis
* ciliary dyskinesia,
* antrochoanal polyp
* fungal sinusitis,
* unilateral nasal polyps, a
* patients who took systemic steroids in the last 6 months before our study were excluded.

Primary outcomes:
measure: SNOT-22 Score
timeFrame: 3 months
Secondary outcomes:
measure: Lund Mackay score
timeFrame: 3 months
Other outcomes:
measure: total nasal polyp score
timeFrame: 3 months
measure: Total Serum IgE
timeFrame: 3 months
measure: the morning plasma cortisol level
timeFrame: 1 month
measure: Absolute Eosinophilic count
timeFrame: 3 months
Locations:
city: Kafrelsheikh
country: Egypt
facility: Kafrelsheikh University hospital
Study officials:
References:
citation: Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.
citation: Kiris M, Muderris T, Yalciner G, Bercin S, Sevil E, Gul F. Intrapolyp steroid injection for nasal polyposis: Randomized trial of safety and efficacy. Laryngoscope. 2016 Aug;126(8):1730-5. doi: 10.1002/lary.25945. Epub 2016 Mar 24.
citation: Hansen MB, Alanin MC. Injection of Steroid in Nasal Polyps: A Systematic Review. Am J Rhinol Allergy. 2020 Nov;34(6):838-845. doi: 10.1177/1945892420936198. Epub 2020 Jun 24.