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

Sponsor

Kafrelsheikh University (Other)

Overall Status

Completed

CT.gov ID

NCT05931744

Collaborator

(none)

120

Enrollment

Location

Arms

21.1

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis With Nasal Polyps	Drug: Budesonide Drug: Prednisone Drug: Saline	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral steroid patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks	Drug: 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
Experimental: Budesonide Intrapolyp injection patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks	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
Placebo Comparator: Saline intrapolyp injection patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks	Drug: Saline saline intrapolyp injection

Arm

Intervention/Treatment

Active Comparator: Oral steroid

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

Drug: 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

Experimental: Budesonide Intrapolyp injection

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

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

Placebo Comparator: Saline intrapolyp injection

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

Drug: Saline

saline intrapolyp injection

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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