The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
NCT ID: NCT05931744
Last Updated: 2023-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2021-05-01
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral steroid
patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks
Prednisone
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
Budesonide Intrapolyp injection
patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks
Budesonide
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
Saline intrapolyp injection
patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks
Saline
saline intrapolyp injection
Interventions
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Budesonide
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
Prednisone
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
Saline
saline intrapolyp injection
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
Yes
Sponsors
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Kafrelsheikh University
OTHER
Responsible Party
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Ibrahim M. Gehad
Principal Investigator
Locations
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Kafrelsheikh University hospital
Kafrelsheikh, Kafrelsheikh, Egypt
Countries
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Other Identifiers
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MKSU 50-7-8
Identifier Type: -
Identifier Source: org_study_id
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