The Role of Budesonide Intrapolyp Injection in CRSwNP

Study Overview
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Brief Summary
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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
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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

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

Conditions
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CRS, Polyp, Nasal

Intervention / Treatment
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* Drug: Budesonide intrapolyp injection
* Drug: Budesonide nasal wash
* Drug: Prednisolone tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide Intrapolyp injection<br>patients are to receive Endoscopic Intrapolyp steroid injection weekly for 5 weeks, using the following technique, where 2 nasal packs soaked in xylometazoline hydrochloride 0.1%  Otrivin adult nasal drops applied one pack in each nostril for 5 minutes before injection, then using the 0° nasal endoscopy patients receive intrapolyp budesonide injection by 0.5 mg/ml budesonide respules commercially available as Pulmicort ampules 1 ml for each nostril using 1 cc 28 gauge needle sterile syringe, where injections carefully distributed amongst visible polyps avoiding visible vessels, No local anesthesia will be used before injections, patients come back to the clinic weekly to complete a series of 5 injections. | Drug: Budesonide intrapolyp injection<br>* intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids<br>* Other names: pulmicort;|
| Active Comparator: budesonide wash<br>patients will be instructed to perform budesonide nasal wash, through a 250 ml squeeze bottle filled with saline, 0.5 mg/ml budesonide Pulmicort ampule added to the solution and half the amount used for each nostril, patients gurgle with antiseptic solution to minimize the risk of oral candidiasis, patients carry out the wash twice daily for one month duration | Drug: Budesonide nasal wash<br>* Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.<br>* Other names: pulmicort;|
| Active Comparator: Oral steroid<br>patients receive oral prednisolone 1 mg/kg/d tapering it by 5 mg/day for 2 weeks, patients will be prescribed omeprazole 20mg protective against gastrointestinal effects of steroid | Drug: Prednisolone tablets<br>* oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.<br>* Other names: solupred;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-22 Score | as a subjective method to assess the patients' quality of life QOL and the severity of the disease prior to treatment and after. All patients will fill the 22 item questionnaire where the severity of each symptom was determined by 5 point scale where 0 no problem, 1 very mild problem, 2 mild or slight problem, 3 moderate problem, 4 severe problem, 5 Problem as bad as it can be Where the sum of each individual item score provides the SNOT-22 score | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lund Mackay score | Mackay CT score as a tool for radiological evaluation of patients with nasal polyps where each sinus is solitary assigned a score from 0 to 2 where 0 = is no opacity , 1 = partial opacity, 2 = complete opacity, where the Osteomeatal complex is given only 0 or 2, each side is evaluated on its own and the sum of all sinus is calculated. A combined score of 24 is the maximum. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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budesonide, CRSwNP, chronic Rhinosinusitis, Nasal polyps, Intrapolyp injection