Chronic Rhinosinusitis With Nasal Polyps
Conditions
Keywords
CRSwNP, Intranasal steroid injection, Budesonide
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
Interventions
DRUGBudesonide
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
DRUGPrednisone
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
DRUGSaline
saline intrapolyp injection
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Egypt
Outcome results
None listed