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The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

17 maart 2022 bijgewerkt door: Nina Irawati, Indonesia University

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

32

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Indonesië
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesië, 10430
        • RSUPN Dr. Cipto Mangunkusumo

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention Group
Subjects will receive radiofrequency turbinate reduction done in the outpatient clinic, followed by pharmacology treatment (intranasal steroid and AH-1) for 8 weeks.
Procedure: Radiofrequency turbinate reduction
Before the radiofrequency turbinate reduction procedure, local anaesthesia will be given by applying a cotton tamponade soaked in lidocaine adrenaline 1:5000 titration and added with xylocaine gel for 10 minutes in both nostrils. Then, a mixture of 1 mL of lidocaine 2% and 2 mL of sodium chloride 0,9% will be infiltrated to both nostrils using 3 mL and 1 mL needles until the inferior turbinates are pale. The radiofrequency probe (made by Sutter, both in monopolar and bipolar modes) will be inserted to the distal inferior turbinate until the black line from the probe is inside the inferior turbinate (approximately 10-12 mm). The procedure will be done for 10 seconds and the insertion of the probe can be done in 2-3 sites. After this, subjects from this group will be treated with pharmacology treatment using intranasal steroid and AH-1 according to ARIA WHO guideline 2008, similar to the pharmacology treatment received by the control group.
Geneesmiddel: Pharmacology treatment
Subjects will be treated with intranasal steroid and AH-1 according to ARIA WHO guideline 2008. Fluticasone furoate will be given twice a day with two sprays (100 µg) for each nostril for 2 weeks, then continue for once a day with two sprays (100 µg). Antihistamine H-1 is given 10 mg, once a day. Pharmacology treatment is given for 4 weeks, then intranasal steroid will be continued for another 4 weeks.
Andere namen:
  • Standaard behandeling
Actieve vergelijker: Control Group
Subjects in the control group will receive only the pharmacology treatment for 8 weeks.
Geneesmiddel: Pharmacology treatment
Subjects will be treated with intranasal steroid and AH-1 according to ARIA WHO guideline 2008. Fluticasone furoate will be given twice a day with two sprays (100 µg) for each nostril for 2 weeks, then continue for once a day with two sprays (100 µg). Antihistamine H-1 is given 10 mg, once a day. Pharmacology treatment is given for 4 weeks, then intranasal steroid will be continued for another 4 weeks.
Andere namen:
  • Standaard behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
VAS score based on TNSS at baseline
Tijdsspanne: Evaluation is done at baseline
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis allergy symptoms, while ≥ 5 indicates that symptoms are not controlled.
Evaluation is done at baseline
VAS score based on TNSS at week 4
Tijdsspanne: Evaluation is done at week 4
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis allergy symptoms, while ≥ 5 indicates that symptoms are not controlled.
Evaluation is done at week 4
VAS score based on TNSS at week 8
Tijdsspanne: Evaluation is done at week 8
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis allergy symptoms, while ≥ 5 indicates that symptoms are not controlled.
Evaluation is done at week 8
Size of inferior turbinate at baseline
Tijdsspanne: Evaluation is done at baseline
The inferior turbinate was evaluated by using nasoendoscopy and Image J™ program was used to determine the size of inferior turbinate.
Evaluation is done at baseline
Size of inferior turbinate at week 4
Tijdsspanne: Evaluation is done at week 4
The inferior turbinate was evaluated by using nasoendoscopy and Image J™ program was used to determine the size of inferior turbinate.
Evaluation is done at week 4
Size of inferior turbinate at week 8
Tijdsspanne: Evaluation is done at week 8
The inferior turbinate was evaluated by using nasoendoscopy and Image J™ program was used to determine the size of inferior turbinate.
Evaluation is done at week 8
PNIF value at baseline
Tijdsspanne: Evaluation is done at baseline
Nasal airflow resistance was evaluated using In-Check Nasal Inspiratory Flow Meter by Clement Clarke International Itd England. The examination was repeated for three times with 30 seconds paused and the highest value was taken.
Evaluation is done at baseline
PNIF value at week 4
Tijdsspanne: Evaluation is done at week 4
Nasal airflow resistance was evaluated using In-Check Nasal Inspiratory Flow Meter by Clement Clarke International Itd England. The examination was repeated for three times with 30 seconds paused and the highest value was taken.
Evaluation is done at week 4
PNIF value at week 8
Tijdsspanne: Evaluation is done at week 8
Nasal airflow resistance was evaluated using In-Check Nasal Inspiratory Flow Meter by Clement Clarke International Itd England. The examination was repeated for three times with 30 seconds paused and the highest value was taken.
Evaluation is done at week 8
Inflammatory mediators at baseline
Tijdsspanne: Evaluation is done at baseline
Inflammatory mediators that will be evaluated are IL-5, ECP, and HSP-70. They were examined from nasal secretions and enzyme-linked immunosorbent assay (ELISA) spectrophotometry is used to evaluate the amount of IL-5, ECP, and HSP-70 in both groups
Evaluation is done at baseline
Inflammatory mediators at week 4
Tijdsspanne: Evaluation is done at week 4
Inflammatory mediators that will be evaluated are IL-5, ECP, and HSP-70. They were examined from nasal secretions and enzyme-linked immunosorbent assay (ELISA) spectrophotometry is used to evaluate the amount of IL-5, ECP, and HSP-70 in both groups
Evaluation is done at week 4
Remodeling components at baseline
Tijdsspanne: Evaluation is done at baseline
Remodeling components that will be evaluated are MMP-9, TIMP-1, and PAI-1. They will be assessed using immunihistochemistry from tissue biopsy of inferior turbinate.
Evaluation is done at baseline
Remodeling components at week 4
Tijdsspanne: Evaluation is done at week 4
Remodeling components that will be evaluated are MMP-9, TIMP-1, and PAI-1. They will be assessed using immunihistochemistry from tissue biopsy of inferior turbinate.
Evaluation is done at week 4

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Indonesia University

Onderzoekers

  • Hoofdonderzoeker: Nina Irawati, MD, Indonesia University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2018

Primaire voltooiing (Werkelijk)

1 februari 2020

Studie voltooiing (Werkelijk)

1 februari 2020

Studieregistratiedata

Eerst ingediend

18 februari 2022

Eerst ingediend dat voldeed aan de QC-criteria

2 maart 2022

Eerst geplaatst (Werkelijk)

11 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

17 maart 2022

Laatst geverifieerd

1 maart 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 18-08-0974

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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