The Role of Budesonide Intrapolyp Injection in CRSwNP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-12-01

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.

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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

Conditions

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CRS Polyp, Nasal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Budesonide Intrapolyp injection

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.

Group Type EXPERIMENTAL

Budesonide intrapolyp injection

Intervention Type DRUG

intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids

budesonide wash

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

Group Type ACTIVE_COMPARATOR

Budesonide nasal wash

Intervention Type DRUG

Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.

Oral steroid

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

Group Type ACTIVE_COMPARATOR

Prednisolone tablets

Intervention Type DRUG

oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.

Interventions

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Budesonide intrapolyp injection

intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids

Intervention Type 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.

Intervention Type DRUG

Prednisolone tablets

oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.

Intervention Type DRUG

Other Intervention Names

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pulmicort pulmicort solupred

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No