Skip to main content
OpenTrials
Completed

NCT Number: NCT05931744

The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kafrelsheikh University hospital

Kafrelsheikh, 37458, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

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

Drug

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

Drug

saline intrapolyp injection

Primary outcomes

  1. Sino-Nasal Outcome Test "SNOT-22" Score

    Time frame: 6 months

    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

  2. CT Lund Mackay

    Time frame: 6 months

    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

  3. Total nasal Polyp score "TNPS"

    Time frame: 6 months

    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

  4. Serum IgE

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.