The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis

Kafrelsheikh University120 enrolled

Overview

To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps

this is a randomized controlled clinical trial where 3 groups with nasal polyps will be treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp injection, Group C with placebo saline intrapolyp injection

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

BudesonideDRUG

after application of topical vasoconstrictor packs into both nasal cavities, using 1 cc 28 gauge needle sterile syringe, one pack of budesonide ampule 0.5 mg/2ml was injected into visible polyps on both cavities 1 ml in each cavity weekly for 5 consecutive weeks

PrednisoneDRUG

patients given oral prednisone 1 mg/ kg with max. dose 70 mg/d divided into two doses for 3 days then tapered gradually for two weeks

SalineDRUG

saline intrapolyp injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All patients with type 2 CRSwNP - * elevated serum IgE \& high absolute eosinophilia * with any grade of nasal polyps * ages between 18 and 60 years old * patients who didn't have any contraindications of systemic steroids Exclusion Criteria: * All patients with previous nasal surgeries * All patients with cystic fibrosis, ciliary dyskinesia, antrochoanal polyp, fungal sinusitis, unilateral nasal polyps, nasal tumors, * patients who took systemic steroids in the last 6 months before our study * patients with any previous nasal surgery

Locations (1)

Kafrelsheikh University hospital

Kafrelsheikh, Kafrelsheikh, Egypt

Outcomes

Primary Outcomes

Sino-Nasal Outcome Test "SNOT-22" Score

subjective method to assess the patient's quality of life "QOL" and the severity of the disease before and after treatment, The lower the score, The better the condition

Time frame: 6 months

CT Lund Mackay

the radiological evaluation of patients with nasal polyps where each sinus was solitarily assigned a score from (0 to 2), where the Osteomeatal Complex was given only (0 or 2), each side was evaluated on its own and the sum of all sinuses was calculated. A combined score of 24 was the maximum. Investigators asked the patients for a CT scan before starting the treatment and 3 months after the completion of each treatment protocol

Time frame: 6 months

Total nasal Polyp score "TNPS"

the clinical assessment of nasal polyps, the total nasal polyp score "TNPS" was used where polyp size was evaluated through endoscopy and given a score from (0 to 3). TNPS was calculated as the sum of the score on each side, and patients were assessed on regular visits before receiving treatment, 1 week after treatment, and after 3 months

Time frame: 6 months

Serum IgE

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.