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

Kafrelsheikh University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Prednisone; Drug: Saline; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT05931744

MKSU 50-7-8

Details and patient eligibility

About

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

Full description

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Oral steroid

Active Comparator group

Description:

patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks

Treatment:

Drug: Prednisone

Budesonide Intrapolyp injection

Experimental group

Description:

patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks

Treatment:

Drug: Budesonide

Saline intrapolyp injection

Placebo Comparator group

Description:

patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks

Treatment:

Drug: Saline