Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
EHA
1 other identifier
interventional
101
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2020
CompletedFirst Submitted
Initial submission to the registry
January 31, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2021
CompletedFebruary 12, 2021
February 1, 2021
1.3 years
January 31, 2021
February 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Results of "total nasal symptom score" surveys
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).
28 days
Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey
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).
28 days
Secondary Outcomes (3)
Nasal smear eosinophil count (percentages)
Two days
Nasal airflow (NAF) (ccm/sn)
Two days
Nasal resistance (NAR) (Pa. s/ml)
Two days
Study Arms (3)
Grup1
ACTIVE COMPARATORNasal 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
ACTIVE COMPARATORNS + 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
ACTIVE COMPARATORNS + 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)
Interventions
TNSS contains 4 parameters in assessing the severity of allergic rhinitis: nasal congestion, runny nose, nasal itching, and sneezing. Each symptom is scored out of 4 points, from 0 to 3. 0, none- there are no complaints 1- mild- any symptom that exists but is not particularly annoying; 2, moderate, - any annoying symptom but does not interfere with daily activities or sleep; 3, severe - any symptom preventing daily activities or disturbing during sleeping. The total score is calculated by summing all the scores of 4 fields, which vary ranges from 0 to 15 .In our study, all patients will be instructed to record their TNSS symptom scores on their diary cards each morning before taking the drug. Patients will be graded on baseline TNSS parameters compared to 4 weeks before starting treatment.
PRQLQ, is a self-administered, disease-specific questionnaire, evaluating physical, emotional, and social status of individuals with AR. It 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 is derived from the average score of all items (20). In our study, the Turkish validated form of PRQLQ was used Patients will be asked to answer PRQLQ questions at the end of each week during treatment. At the end of the treatment, an average of 4 weeks will be taken as the PRQLQ score. Basal PRQLQ questions will be evaluated by the participants based on 4 weeks prior to treatment.
In anterior rhinoscopy, nasal cytology will be scraped off the middle part of the lower turbinate with the help of a small sterile cotton swab. The cellular material obtained will be fixed by air drying on a glass slide and then stained by the May-Grünwald-Giemsa method. Preparations that do not contain respiratory epithelium or contain less than 10 epithelium at high magnification will be excluded from the study. A percentage of cells per 100 cells will be reported. NECs (nasal eosinophilic count) will be evaluated according to the quantitative classification of Gelardi et al. An experienced cytologist who is blind to the study groups will perform this test. Eosinophil percentages in nasal smears of all patients will be evaluated before and after the treatment.
Children's right, left and total nasal airway resistance (NAR) and nasal airflow (NAF) will be measured with active anterior rhinomanometry ZAN 100 USB Rhinomanometry (Longmont, Colo., USA). In the evaluation, the NAR- pressure difference / air flow (R = P / V) formula will be used at a constant 150 Pascal prescribed by the European Rinomanometry Standardization Committee in 1984. After the patient is rested for 20 minutes, measurements will be made at 20-22 ° C and the nasal secretion will be cleared. NAR and NAF values of the participants will be measured before starting treatment and 4 weeks after treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11
Ankara, Etlik, 06010, Turkey (Türkiye)
Gülhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Related Publications (2)
Savietto E, Marioni G, Maculan P, Pettorelli A, Scarpa B, Simoni E, Astolfi L, Marchese-Ragona R, Ottaviano G. Effectiveness of micronized nasal irrigations with hyaluronic acid/isotonic saline solution in non-polipoid chronic rhinosinusitis: A prospective, randomized, double-blind, controlled study. Am J Otolaryngol. 2020 Jul-Aug;41(4):102502. doi: 10.1016/j.amjoto.2020.102502. Epub 2020 May 7.
PMID: 32460989RESULTErcan N, Demirel F, Yesillik S, Bolat A, Kartal O. Efficacy of sodium hyaluronate in relieving nasal symptoms of children with intermittent allergic rhinitis: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2925-2934. doi: 10.1007/s00405-021-07073-0. Epub 2021 Sep 16.
PMID: 34529156DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nazli Ercan, MD
University of Health Sciences, Gulhane Research and Training Hospital, Department of Pediatrics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Allergy and Immunology Specialist
Study Record Dates
First Submitted
January 31, 2021
First Posted
February 12, 2021
Study Start
March 3, 2019
Primary Completion
June 6, 2020
Study Completion
June 6, 2021
Last Updated
February 12, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share