The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title: The Effect of Early Radiofrequency Turbinate Reduction, Intranasal Steroid, and Antihistamine H-1 on Persistent Allergic Rhinitis: A Randomized Clinical Trial

Status Completed

Clinical Trial Summary

The primary outcome of this study is to evaluate the effect of radiofrequency turbinate reduction as an initial treatment on clinical improvement (using visual analogue scale based on total nasal symptoms score, peak nasal inspiratory flow, and turbinate size using ImageJ), inflammatory mediators (ELISA from nasal secretions was performed to measure ECP, IL-5, and HSP-70), and remodeling markers (through nasal biopsy followed by immunohistochemistry examination to evaluate MMP-9, TIMP-1, and PAI-1).

In this randomized, controlled trial, 32 patients with moderate-severe persistent AR were randomly divided into 2 groups. Intervention group received radiofrequency turbinate reduction followed by intranasal steroid and antihistamine H-1(AH-1), control group received intranasal steroid and AH-1. Both groups were evaluated for clinical improvement in week 4 and 8 after treatment, inflammatory mediators and remodeling markers in week 4 after treatment.

Clinical Trial Description

The study compares 2 groups of moderate-severe persistent allergic rhinitis (AR). The intervention group receives radiofrequency turbinate reduction followed by pharmacology treatment (intranasal steroid and AH-1) while the control group receives only pharmacology treatment.

Diagnosis of AR will be made through clinical history, physical examination, and skin puncture test. Patients aged 18-55 years old with moderate-severe persistent AR who come to the outpatient clinic and have signed the informed consent form will be included in this study. Moderate-severe AR is defined as having AR symptoms for more than 4 days in a week and more than 4 weeks, with symptoms affecting the subjects' quality of life. Patients will be assigned to two groups of treatment randomly with a single blind block randomization. ;

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

• NCT number: NCT05276336
• Study type: Interventional
• Source: Indonesia University
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2018
• Completion date: February 1, 2020