CRS, Polyp, Nasal
Conditions
Keywords
budesonide, CRSwNP, chronic Rhinosinusitis, Nasal polyps, Intrapolyp injection
Brief summary
Chronic rhinosinusitis with nasal polyps is a common nasal comorbidity with a wide range of symptoms that might cause severe distress and disabilities for patients. Many patients undergo repeated courses of systemic steroids and are exposed to various adverse effects. many cases finally revert to surgery. Budesonide was safely used as a nasal wash in cases of nasal polyps, our aim to determine If intrapolyp injection is a better method for delivering budesonide.
Detailed description
Chronic Rhinosinusitis with nasal polyps can be a severely debilitating disease, it's classically treated with steroids, and different methods of steroid delivery have been used for years. patients usually receive repeated courses of systemic steroids and experience many side effects. there have been trials of intrapolyp injection of steroids, especially triamcinolone acetate. these trials concluded that it's a safe intervention. Budesonide has been used as a nasal wash frequently in cases of nasal polyps, it also has been used safely as an intratympanic injection for cases of sudden hearing loss.. it's used as a systemic steroid in cases of inflammatory bowel diseases. The aim of our study is to test whether polyp injection is a more effective method of budesonide delivery and less dependent on subjective compliance rather than irrigation, and If it has comparable results with oral systemic steroids on polyps
Interventions
DRUGBudesonide intrapolyp injection
intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids
DRUGBudesonide nasal wash
Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.
oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* All patients with type 2 CRSwNP -indicated by elevated serum IgE & high absolute Eosinophilia- with nasal polyps whose * ages between 18 and 60 years old * who don't have any contraindications of systemic steroids such as glaucoma, peptic ulcer, acute psychosis, chronic infections, severe osteoporosis, severe hypertension, uncontrolled diabetes mellitus, history of thromboembolic events
Exclusion criteria
* cystic fibrosis * ciliary dyskinesia, * antrochoanal polyp * fungal sinusitis, * unilateral nasal polyps, a * patients who took systemic steroids in the last 6 months before our study were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-22 Score | 3 months | as a subjective method to assess the patients' quality of life QOL and the severity of the disease prior to treatment and after. All patients will fill the 22 item questionnaire where the severity of each symptom was determined by 5 point scale where 0 no problem, 1 very mild problem, 2 mild or slight problem, 3 moderate problem, 4 severe problem, 5 Problem as bad as it can be Where the sum of each individual item score provides the SNOT-22 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lund Mackay score | 3 months | Mackay CT score as a tool for radiological evaluation of patients with nasal polyps where each sinus is solitary assigned a score from 0 to 2 where 0 = is no opacity , 1 = partial opacity, 2 = complete opacity, where the Osteomeatal complex is given only 0 or 2, each side is evaluated on its own and the sum of all sinus is calculated. A combined score of 24 is the maximum. |
Other
| Measure | Time frame | Description |
|---|---|---|
| total nasal polyp score | 3 months | the total nasal polyp score TNPS will be used were polyp size evaluated through endoscopy and given a score from 0 to 3 where 0 = no visible polyps, 1= mild polyposis polyps not reaching the upper edge of the inferior turbinate, 2= moderate polyposis polyps reaching beyond the upper edge but not the lower edge of inferior turbinate, 3= severe polyposis polyps reaching below the lower edge of the inferior turbinate or reaching the floor of the nose TNPS calculated as the sum of the score on each side |
| Total Serum IgE | 3 months | Serum IgE of patients in all groups will be measured before the start, after course completion and after 3 months of receiving treatment |
| the morning plasma cortisol level | 1 month | — |
| Absolute Eosinophilic count | 3 months | absolute eosinophilic count of patients in all groups will be measured before the start, after course completion and after 3 months of receiving treatment |
Countries
Egypt
Contacts
Primary Contactibrahim mahmoud
Outcome results
None listed