NCT05931744

Brief Summary

To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

May 12, 2023

Last Update Submit

July 3, 2023

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

CRSwNPIntranasal steroid injectionBudesonide

Outcome Measures

Primary Outcomes (4)

  • 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

    6 months

  • 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

    6 months

  • 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

    6 months

  • Serum IgE

    1 month

Study Arms (3)

Oral steroid

ACTIVE COMPARATOR

patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks

Drug: Prednisone

Budesonide Intrapolyp injection

EXPERIMENTAL

patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks

Drug: Budesonide

Saline intrapolyp injection

PLACEBO COMPARATOR

patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks

Drug: Saline

Interventions

BudesonideDRUG

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

Budesonide Intrapolyp injection
PrednisoneDRUG

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

Oral steroid
SalineDRUG

saline intrapolyp injection

Saline intrapolyp injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University hospital

Kafrelsheikh, Kafrelsheikh, 37458, Egypt

Location

MeSH Terms

Interventions

BudesonidePrednisoneSodium Chloride

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2023

First Posted

July 5, 2023

Study Start

May 1, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Locations

EG(1)