The Role of Budesonide Intrapolyp Injection in CRSwNP

CRS Clinical Trial

Official title:

The Role of Budesonide Intrapolyp Injection in Chronic Rhinosinusitis With Nasal Polyps. A Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474924
• Other study ID #: MKSU 50-7-7
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Kafrelsheikh University
• Contact: ibrahim mahmoud
• Phone: +201011714089
• Email: ibrahimgehad94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• CRS
• Nasal Polyps
• Polyps

Intervention

Drug:
• Budesonide intrapolyp injection
intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids
• Budesonide nasal wash
Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.
• Prednisolone tablets
oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University hospital	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

Kiris M, Muderris T, Yalçiner 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	3 months
Other	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
Other	the morning plasma cortisol level		1 month
Other	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
Primary	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
Secondary	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