The Role of Budesonide Intrapolyp Injection in CRSwNP
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 26, 2022
July 1, 2022
1 month
July 18, 2022
July 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Lund Mackay score
3 months
Other Outcomes (4)
total nasal polyp score
3 months
Total Serum IgE
3 months
the morning plasma cortisol level
1 month
- +1 more other outcomes
Study Arms (3)
Budesonide Intrapolyp injection
EXPERIMENTALpatients 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.
budesonide wash
ACTIVE COMPARATORpatients 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
Oral steroid
ACTIVE COMPARATORpatients 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
Interventions
intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kafrelsheikh University hospital
Kafrelsheikh, Kafrelsheikh, 37458, Egypt
Related Publications (3)
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.
PMID: 27440128BACKGROUNDKiris 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.
PMID: 27011266BACKGROUNDHansen 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.
PMID: 32579018RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ENT Specialist
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 26, 2022
Study Start
August 1, 2022
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
July 26, 2022
Record last verified: 2022-07