The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis
17 mars 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesien, 10430
- RSUPN Dr. Cipto Mangunkusumo
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
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.
Andra namn:
|
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Aktiv komparator: Control Group
Subjects in the control group will receive only the pharmacology treatment for 8 weeks.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
VAS score based on TNSS at baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
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Samarbetspartners och utredare
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Sponsor
Utredare
- Huvudutredare: Nina Irawati, MD, Indonesia University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2018
Primärt slutförande (Faktisk)
1 februari 2020
Avslutad studie (Faktisk)
1 februari 2020
Studieregistreringsdatum
Först inskickad
18 februari 2022
Först inskickad som uppfyllde QC-kriterierna
2 mars 2022
Första postat (Faktisk)
11 mars 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 18-08-0974
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