Clinical trial NCT04752956: Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
Official title: Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Results of "total nasal symptom score" surveys
timeFrame: 28 days
measure: Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey
timeFrame: 28 days
Secondary outcomes:
measure: Nasal smear eosinophil count (percentages)
timeFrame: Two days
measure: Nasal airflow (NAF) (ccm/sn)
timeFrame: Two days
measure: Nasal resistance (NAR) (Pa. s/ml)
timeFrame: Two days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11
state: Etlik
city: Ankara
country: Turkey
facility: Gülhane Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Gulhane Research and Training Hospital, Department of Pediatrics
name: Nazli Ercan, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ercan 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.