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NCT05276336

The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

Completed Phase 3 Last updated 31 March 2022
What this trial tests

Phase 3 trial testing Radiofrequency turbinate reduction in Allergic Rhinitis in 32 participants. Completed in 1 February 2020.

Timeline
1 July 2018
Primary endpoint
1 February 2020
1 February 2020

Quick facts

Lead sponsorIndonesia University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment32
Start date1 July 2018
Primary completion1 February 2020
Estimated completion1 February 2020
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Indonesia University

Who can join

Adults 18 to 70, any sex, with Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Allergic Rhinitis

Currently open trials in the same condition.

Other Indonesia University trials

Trials by the same sponsor.

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Data sources for this page

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