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

Phase 2

Completed

• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Interventions: Drug: Budesonide; Drug: Saline; Drug: Prednisone

• Registration Number: NCT05931744
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-05-12
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide Intrapolyp injection	Budesonide	patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks
Saline intrapolyp injection	Saline	patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks
Oral steroid	Prednisone	patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks

Primary Outcome Measures

Name	Time	Method
Sino-Nasal Outcome Test "SNOT-22" Score	6 months	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
CT Lund Mackay	6 months	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
Total nasal Polyp score "TNPS"	6 months	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
Serum IgE	1 month

Trial Locations

Locations (1)

Kafrelsheikh University hospital; 🇪🇬 Kafrelsheikh, Egypt