Clinical trial NCT05276336: The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis
Official title: The Effect of Early Radiofrequency Turbinate Reduction, Intranasal Steroid, and Antihistamine H-1 on Persistent Allergic Rhinitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: allergic
histamine antagonist
radiofrequency turbinate reduction
rhinitis
steroid
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS score based on TNSS at baseline
timeFrame: Evaluation is done at baseline
measure: VAS score based on TNSS at week 4
timeFrame: Evaluation is done at week 4
measure: VAS score based on TNSS at week 8
timeFrame: Evaluation is done at week 8
measure: Size of inferior turbinate at baseline
timeFrame: Evaluation is done at baseline
measure: Size of inferior turbinate at week 4
timeFrame: Evaluation is done at week 4
measure: Size of inferior turbinate at week 8
timeFrame: Evaluation is done at week 8
measure: PNIF value at baseline
timeFrame: Evaluation is done at baseline
measure: PNIF value at week 4
timeFrame: Evaluation is done at week 4
measure: PNIF value at week 8
timeFrame: Evaluation is done at week 8
measure: Inflammatory mediators at baseline
timeFrame: Evaluation is done at baseline
measure: Inflammatory mediators at week 4
timeFrame: Evaluation is done at week 4
measure: Remodeling components at baseline
timeFrame: Evaluation is done at baseline
measure: Remodeling components at week 4
timeFrame: Evaluation is done at week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Nina Irawati, MD
role: PRINCIPAL_INVESTIGATOR
References: