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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931744
• Other study ID #: MKSU 50-7-8
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• Budesonide
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
• Prednisone
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
• Saline
saline intrapolyp injection

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University hospital	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	6 months
Primary	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	6 months
Primary	Serum IgE		1 month