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The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

17 marzo 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Droga: 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.
Altri nomi:
  • Trattamento standard
Comparatore attivo: Control Group
Subjects in the control group will receive only the pharmacology treatment for 8 weeks.
Droga: 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.
Altri nomi:
  • Trattamento standard

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
VAS score based on TNSS at baseline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Indonesia University

Investigatori

  • Investigatore principale: Nina Irawati, MD, Indonesia University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2018

Completamento primario (Effettivo)

1 febbraio 2020

Completamento dello studio (Effettivo)

1 febbraio 2020

Date di iscrizione allo studio

Primo inviato

18 febbraio 2022

Primo inviato che soddisfa i criteri di controllo qualità

2 marzo 2022

Primo Inserito (Effettivo)

11 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 18-08-0974

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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