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

Last updated: February 10, 2021
Sponsor: Saglik Bilimleri Universitesi
Overall Status: Active - Enrolling

Phase

N/A

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT04752956
HA2021
  • Ages 6-12
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Pediatric patients between 6 to 12-year-old;
  • Children must have a clinical history concordant to seasonal allergic rhinitis of theprevious 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 3mm 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 daysduring the run-in period.

Exclusion

Exclusion Criteria:

  • Children who were treated with systemic/topical nasal corticosteroids, antihistaminesor 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, andostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomicaldisorder, metabolic disease, or congenital disease.
  • Phone calls will measure children's adherence rate to treatment protocols, andparticipants determined to have treatment protocol adherence rates below 85% will beexcluded.

Study Design

Total Participants: 101
Study Start date:
March 03, 2019
Estimated Completion Date:
June 06, 2021

Connect with a study center

  • Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Sağlam Cd No:11

    Ankara, Etlik 06010
    Turkey

    Site Not Available

  • Gülhane Training and Research Hospital

    Ankara, 06010
    Turkey

    Site Not Available

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