Allergic Rhinitis
Conditions
Keywords
allergic, histamine antagonist, radiofrequency turbinate reduction, rhinitis, steroid
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.
Interventions
PROCEDURERadiofrequency 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.
DRUGPharmacology 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS score based on TNSS at baseline | 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. |
| VAS score based on TNSS at week 4 | 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. |
| Size of inferior turbinate at baseline | 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. |
| VAS score based on TNSS at week 8 | 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. |
| Size of inferior turbinate at week 4 | 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. |
| Size of inferior turbinate at week 8 | 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. |
| PNIF value at baseline | 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. |
| PNIF value at week 4 | 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. |
| PNIF value at week 8 | 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. |
| Inflammatory mediators at baseline | 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 |
| Inflammatory mediators at week 4 | 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 |
| Remodeling components at baseline | 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. |
| Remodeling components at week 4 | 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. |
Countries
Indonesia
Outcome results
None listed