Back to resultsThe Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
Primary Purpose
Chronic Rhinosinusitis With Nasal Polyps
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Budesonide
Prednisone
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps focused on measuring CRSwNP, Intranasal steroid injection, Budesonide
Eligibility Criteria
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
Sites / Locations
- Kafrelsheikh University hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Oral steroid
Budesonide Intrapolyp injection
Saline intrapolyp injection
Arm Description
patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks
patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks
patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks
Outcomes
Primary Outcome Measures
Sino-Nasal Outcome Test "SNOT-22" Score
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
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"
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05931744
Brief Title
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
Official Title
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis With Nasal Polyps
Keywords
CRSwNP, Intranasal steroid injection, Budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral steroid
Arm Type
Active Comparator
Arm Description
patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks
Arm Title
Budesonide Intrapolyp injection
Arm Type
Experimental
Arm Description
patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks
Arm Title
Saline intrapolyp injection
Arm Type
Placebo Comparator
Arm Description
patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
saline intrapolyp injection
Primary Outcome Measure Information:
Title
Sino-Nasal Outcome Test "SNOT-22" Score
Description
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
Time Frame
6 months
Title
CT Lund Mackay
Description
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
Time Frame
6 months
Title
Total nasal Polyp score "TNPS"
Description
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
Time Frame
6 months
Title
Serum IgE
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Kafrelsheikh University hospital
City
Kafrelsheikh
ZIP/Postal Code
37458
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
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