The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Allergic Rhinitis

Treatments: Procedure: Radiofrequency turbinate reduction; Drug: Pharmacology treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05276336

18-08-0974

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with moderate-severe persistent allergic rhinitis who come to the outpatient clinic and has signed the informed consent form.

Exclusion criteria

• Smokers
• Septum deviation in nasal valve without septal swell body
• Unilateral inferior turbinate hypertrophy caused by septum deviation
• Pregnant
• Severe systemic disease
• Acute rhinitis or rhinosinusitis within 6 weeks before the study period
• Nasal polyp
• Nasal or paranasal tumor
• Subjects who had received other methods of inferior turbinate reduction, posterior nasal neurectomy, functional endoscopic sinus surgery, Caldwell Luc
• Subjects who had received topical steroid for 4 weeks before the study period
• Coagulation disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Subjects will receive radiofrequency turbinate reduction done in the outpatient clinic, followed by pharmacology treatment (intranasal steroid and AH-1) for 8 weeks.

Treatment:

Drug: Pharmacology treatment

Procedure: Radiofrequency turbinate reduction

Control Group

Active Comparator group

Description:

Subjects in the control group will receive only the pharmacology treatment for 8 weeks.

Treatment:

Drug: Pharmacology treatment