The Role of Budesonide Intrapolyp Injection in CRSwNP

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Budesonide intrapolyp injection

Budesonide nasal wash

Prednisolone tablets

About this trial

This is an interventional treatment trial for CRS focused on measuring budesonide, CRSwNP, chronic Rhinosinusitis, Nasal polyps, Intrapolyp injection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kafrelsheikh University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Budesonide Intrapolyp injection

budesonide wash

Oral steroid

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05474924

First Posted

July 18, 2022

Last Updated

July 24, 2022

Sponsor

Kafrelsheikh University

1. Study Identification

Unique Protocol Identification Number

NCT05474924

Brief Title

The Role of Budesonide Intrapolyp Injection in CRSwNP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Anticipated)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

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

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CRS, Polyp, Nasal

Keywords

budesonide, CRSwNP, chronic Rhinosinusitis, Nasal polyps, Intrapolyp injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Budesonide Intrapolyp injection

Arm Type

Experimental

Arm Description

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.

Arm Title

budesonide wash

Arm Type

Active Comparator

Arm Description

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

Arm Title

Oral steroid

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Budesonide intrapolyp injection

Other Intervention Name(s)

pulmicort

Intervention Description

intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids

Intervention Type

Drug

Intervention Name(s)

Budesonide nasal wash

Other Intervention Name(s)

pulmicort

Intervention Description

Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.

Intervention Type

Drug

Intervention Name(s)

Prednisolone tablets

Other Intervention Name(s)

solupred

Intervention Description

oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.

Primary Outcome Measure Information:

Title

SNOT-22 Score

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Lund Mackay score

Description

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.

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

total nasal polyp score

Description

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

Time Frame

3 months

Title

Total Serum IgE

Description

Serum IgE of patients in all groups will be measured before the start, after course completion and after 3 months of receiving treatment

Time Frame

3 months

Title

the morning plasma cortisol level

Time Frame

1 month

Title

Absolute Eosinophilic count

Description

absolute eosinophilic count of patients in all groups will be measured before the start, after course completion and after 3 months of receiving treatment

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ibrahim mahmoud

Phone

+201011714089

Email

ibrahimgehad94@gmail.com

Facility Information:

Facility Name

Kafrelsheikh University hospital

City

Kafrelsheikh

ZIP/Postal Code

37458

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ibrahim mahmoud

Phone

01556685586

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27440128

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.

Results Reference

background

PubMed Identifier

27011266

Citation

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.

Results Reference

background

PubMed Identifier

32579018

Citation

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.

Results Reference

result

CRS, Polyp, Nasal

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial