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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide Intrapolyp injection | Experimental | patients are to receive Endoscopic Intrapolyp steroid injection weekly for 5 weeks, using the following technique, where 2 nasal packs soaked in xylometazoline hydrochloride 0.1% " Otrivin adult nasal drops" applied one pack in each nostril for 5 minutes before injection, then using the 0° nasal endoscopy patients receive intrapolyp budesonide injection by 0.5 mg/ml budesonide respules "commercially available as Pulmicort ampules" 1 ml for each nostril using 1 cc 28 gauge needle sterile syringe, where injections carefully distributed amongst visible polyps avoiding visible vessels, No local anesthesia will be used before injections, patients come back to the clinic weekly to complete a series of 5 injections. |
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| budesonide wash | Active Comparator | patients will be instructed to perform budesonide nasal wash, through a 250 ml squeeze bottle filled with saline, 0.5 mg/ml budesonide "Pulmicort ampule" added to the solution and half the amount used for each nostril, patients gurgle with antiseptic solution to minimize the risk of oral candidiasis, patients carry out the wash twice daily for one month duration |
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| Oral steroid | Active Comparator | patients receive oral prednisolone 1 mg/kg/d tapering it by 5 mg/day for 2 weeks, patients will be prescribed omeprazole 20mg protective against gastrointestinal effects of steroid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide intrapolyp injection | Drug | intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids |
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| Measure | Description | Time Frame |
|---|---|---|
| SNOT-22 Score | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lund Mackay score | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| total nasal polyp score | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ibrahim mahmoud | Contact | +201011714089 | ibrahimgehad94@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University hospital | Recruiting | Kafrelsheikh | Kafrelsheikh | 37458 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27440128 | Background | Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21. | |
| 27011266 | Background | Kiris M, Muderris T, Yalciner G, Bercin S, Sevil E, Gul F. Intrapolyp steroid injection for nasal polyposis: Randomized trial of safety and efficacy. Laryngoscope. 2016 Aug;126(8):1730-5. doi: 10.1002/lary.25945. Epub 2016 Mar 24. |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide nasal wash | Drug | Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle. |
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| Prednisolone tablets | Drug | oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks. |
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| 3 months |
| Total Serum IgE | Serum IgE of patients in all groups will be measured before the start, after course completion and after 3 months of receiving treatment | 3 months |
| the morning plasma cortisol level | 1 month |
| Absolute Eosinophilic count | absolute eosinophilic count of patients in all groups will be measured before the start, after course completion and after 3 months of receiving treatment | 3 months |
| 32579018 | Result | Hansen MB, Alanin MC. Injection of Steroid in Nasal Polyps: A Systematic Review. Am J Rhinol Allergy. 2020 Nov;34(6):838-845. doi: 10.1177/1945892420936198. Epub 2020 Jun 24. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |