ClinicalTrials.Veeva

Menu

The Role of Budesonide Intrapolyp Injection in CRSwNP

K

Kafrelsheikh University

Status and phase

Enrolling
Phase 4

Conditions

Polyp, Nasal
CRS

Treatments

Drug: Budesonide intrapolyp injection
Drug: Budesonide nasal wash
Drug: Prednisolone tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT05474924
MKSU 50-7-7

Details and patient eligibility

About

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.

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Budesonide Intrapolyp injection
Experimental group
Description:
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.
Treatment:
Drug: Budesonide intrapolyp injection
budesonide wash
Active Comparator group
Description:
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
Treatment:
Drug: Budesonide nasal wash
Oral steroid
Active Comparator group
Description:
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
Treatment:
Drug: Prednisolone tablets

Trial contacts and locations

1

Loading...

Central trial contact

ibrahim mahmoud

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems