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

Study Overview
=================
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

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

Conditions
-----------------
Chronic Rhinosinusitis With Nasal Polyps

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Prednisone
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Serum IgE |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRSwNP, Intranasal steroid injection, Budesonide