The Role of Budesonide Intrapolyp Injection in CRSwNP

July 24, 2022 updated by: Ibrahim M. Gehad, Kafrelsheikh University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Kafrelsheikh, Egypt, 37458
        • Recruiting
        • Kafrelsheikh University hospital
        • Contact:
          • ibrahim mahmoud
          • Phone Number: 01556685586

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide Intrapolyp injection
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.
Drug: Budesonide intrapolyp injection
intrapolyp injection of budesonide in cases of nasal polyps and assessment of side effects compared to systemic steroids
Other Names:
  • pulmicort
Active Comparator: budesonide wash
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
Drug: Budesonide nasal wash
Budesonide Nasal wash in cases of nasal polyp 0.5 mg/2ml added to 250 ml normal saline using squeeze bottle.
Other Names:
  • pulmicort
Active Comparator: Oral steroid
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
Drug: Prednisolone tablets
oral prednisolone tablet dosage 1 mg/kg/d tapered daily for 2 weeks.
Other Names:
  • solupred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNOT-22 Score
Time Frame: 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lund Mackay score
Time Frame: 3 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
total nasal polyp score
Time Frame: 3 months
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
Total Serum IgE
Time Frame: 3 months
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
the morning plasma cortisol level
Time Frame: 1 month
1 month
Absolute Eosinophilic count
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKSU 50-7-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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