Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis

Not Applicable

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Other: "Total nasal symptom score" (TNSS); Behavioral: Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ); Diagnostic Test: Nasal cytology; Diagnostic Test: anterior rhinomanometry

• Registration Number: NCT04752956
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic acid (HA) solution and normal saline (NSS) to nasal steroid (NS) therapy as add - on therapy in improving quality of life and reducing nasal symptom scores of children with seasonal AR (SAR) with regards to NS therapy. Our secondary purpose was to demonstrate the effects on eosinophil count in nasal cytology (NEC), nasal airflow (NAF), and resistance (NAR).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-03
• Primary Completion: 2020-06-06
• Study First Submitted: 2021-01-31
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-12
• Last Update Posted: 2021-02-12
• Study Completion: 2021-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Pediatric patients between 6 to 12-year-old;
• Children must have a clinical history concordant to seasonal allergic rhinitis of the previous year;
• Children must have skin prick test (SPT) positivity to pollen (tree, grass, or weed) (Positive SPT is defined as; skin reaction with within 15 minutes after the test and 3 mm larger swelling compared to the negative control test; ALK, Hørsholm, Denmark)
• Children must have a total nasal symptom score (TNSS) of 4 or more on 4 of 7 days during the run-in period.

Exclusion Criteria

• Children who were treated with systemic/topical nasal corticosteroids, antihistamines or antibiotics, leukotriene receptor antagonists 4 weeks before the examination,
• those who had upper or lower respiratory tract infections;
• recipients of recent or ongoing allergen immunotherapy;
• active smokers;
• those with cystic fibrosis, immunodeficiency, septal deviation, nasal polyps, and ostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomical disorder, metabolic disease, or congenital disease.
• Phone calls will measure children's adherence rate to treatment protocols, and participants determined to have treatment protocol adherence rates below 85% will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup1	Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)	Nasal steroid spray only (NS) (Each dose contains 27.5 micrograms of fluticasone furoate; administered single dose per day as 1 puff through both nostrils)
Grup 2	Nasal cytology	NS + administered ambient temperature normal saline (NSS) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (NSS; 0,09% NaCl, pH:4-5)
Grup 3	Nasal cytology	NS + administered ambient temperature hyaluronic acid (HA) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (Nasorinse plus pediatric® Ingredients: water, sodium chlorine, sodium bicarbonate, and HA; pH balanced)
Grup 3	anterior rhinomanometry	NS + administered ambient temperature hyaluronic acid (HA) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (Nasorinse plus pediatric® Ingredients: water, sodium chlorine, sodium bicarbonate, and HA; pH balanced)
Grup1	"Total nasal symptom score" (TNSS)	Nasal steroid spray only (NS) (Each dose contains 27.5 micrograms of fluticasone furoate; administered single dose per day as 1 puff through both nostrils)
Grup1	Nasal cytology	Nasal steroid spray only (NS) (Each dose contains 27.5 micrograms of fluticasone furoate; administered single dose per day as 1 puff through both nostrils)
Grup 2	Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)	NS + administered ambient temperature normal saline (NSS) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (NSS; 0,09% NaCl, pH:4-5)
Grup 3	"Total nasal symptom score" (TNSS)	NS + administered ambient temperature hyaluronic acid (HA) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (Nasorinse plus pediatric® Ingredients: water, sodium chlorine, sodium bicarbonate, and HA; pH balanced)
Grup 3	Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)	NS + administered ambient temperature hyaluronic acid (HA) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (Nasorinse plus pediatric® Ingredients: water, sodium chlorine, sodium bicarbonate, and HA; pH balanced)
Grup1	anterior rhinomanometry	Nasal steroid spray only (NS) (Each dose contains 27.5 micrograms of fluticasone furoate; administered single dose per day as 1 puff through both nostrils)
Grup 2	"Total nasal symptom score" (TNSS)	NS + administered ambient temperature normal saline (NSS) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (NSS; 0,09% NaCl, pH:4-5)
Grup 2	anterior rhinomanometry	NS + administered ambient temperature normal saline (NSS) through both nostrils by means of nasal douche device twice a day 15 minutes before NS. (NSS; 0,09% NaCl, pH:4-5)

Primary Outcome Measures

Name	Time	Method
Results of "total nasal symptom score" surveys	28 days	The primary outcome will be to understand whether nasal irrigation with hyaluronic acid (HA) solution will be beneficial as add-on therapy in children who are already receiving nasal steroid (NS) therapy.; Total Nasal Symptom Scores (TNSS) of all participants (the study and control groups) will be used in grading the symptom relief of seasonal allergic rhinitis.; Each symptom (nasal congestion, runny nose, nasal itching, and sneezing) will be graded from 0-3 (0=None, 1=Mild, 2=Moderate, 3=Severe) by the participants during the screening. No special unit for the scoring system is identified according to TNSS (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome).
Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey	28 days	PRQLQ is a self-administered, disease-specific questionnaire and the survey contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score will be derived from the average score of all items.; No special unit for the scoring system is identified according to PRQLQ (Only scores mentioned with numbers will be analyzed with SPSS, and the percentages of symptoms will be the primary outcome 2).

Secondary Outcome Measures

Name	Time	Method
Nasal resistance (NAR) (Pa. s/ml)	Two days	Nasal resistance (NAR) will be measured with active anterior rhinomanometry ZAN 100 USB Rhinomanometry device (Longmont, Colo., USA). In the evaluation, the formula NAR- pressure difference/airflow (R = P/V) will be used in the constant 150 Pascal stipulated by the European Rhinomanometry Standardization Committee in 1984.
Nasal smear eosinophil count (percentages)	Two days	• Nasal cytology in anterior rhinoscopy, the middle part of the lower concave will be scraped with the help of a small sterile cotton swab. Slides will be first screened under microscopes to determine the adequacy and cellular areas of the sample at 100 magnification. Slides will be dripped immersion oil and screened under an optic microscope x 1.000 magnification equipped with a digital camera. Analysis of rhino cystograms will involve screening at least 50 fields (300 cells). A percentage of the cell per 100 cells will be reported. NECs (nasal eosinophilic count) will be evaluated according to quantitative classification system described previously by Gelardi et al. Grade 0: No cell; Grade ½: 0,1-1% Eosinophil; Grade 1: 1.1-5% Eosinophil; Grade 2: 5-15% Eosinophil; Grade 3: 15-20% Eosinophil; Grade 4: \> 20% Eosinophil. Eosinophil percentages in nasal smears of all patients will be evaluated before and at the end of treatment.
Nasal airflow (NAF) (ccm/sn)	Two days	Nasal airflow (NAF) will be measured by means of active anterior rhinomanometry ZAN 100 USB Rhinomanometry (Longmont, Colo., USA) device. Measurements will be conducted at 20-22 °C after the patient rests for 20 minutes and the nasal secretion will be cleaned. NAF values of the participants will be measured before initiating the treatment and after 4 weeks of the treatment.

Trial Locations

Locations (2)

Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11; 🇹🇷 Ankara, Etlik, Turkey

Gülhane Training and Research Hospital; 🇹🇷 Ankara, Turkey