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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

"Total nasal symptom score" (TNSS)

Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)

Nasal cytology

anterior rhinomanometry

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Grup1

Grup 2

Grup 3

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Nasal smear eosinophil count (percentages)

• 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)

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.

Nasal resistance (NAR) (Pa. s/ml)

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.

Full Information

NCT ID

NCT04752956

First Posted

January 31, 2021

Last Updated

February 10, 2021

Sponsor

Saglik Bilimleri Universitesi

1. Study Identification

Unique Protocol Identification Number

NCT04752956

Brief Title

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

Acronym

EHA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 3, 2019 (Actual)

Primary Completion Date

June 6, 2020 (Actual)

Study Completion Date

June 6, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Grup1

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Grup 2

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Grup 3

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

"Total nasal symptom score" (TNSS)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Paediatric Rhinoconjunctivitis Quality of Life Questionnaire" (PRQLQ)

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Nasal cytology

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

anterior rhinomanometry

Intervention Description

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.

Primary Outcome Measure Information:

Title

Results of "total nasal symptom score" surveys

Description

Time Frame

28 days

Title

Results of "Pediatric rhinoconjunctivitis quality of life questionnaire" survey

Description

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Nasal smear eosinophil count (percentages)

Description

Time Frame

Two days

Title

Nasal airflow (NAF) (ccm/sn)

Description

Time Frame

Two days

Title

Nasal resistance (NAR) (Pa. s/ml)

Description

Time Frame

Two days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nazli Ercan, MD

Organizational Affiliation

University of Health Sciences, Gulhane Research and Training Hospital, Department of Pediatrics

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Ankara

State/Province

Etlik

ZIP/Postal Code

06010

Country

Turkey

Facility Name

Gülhane Training and Research Hospital

City

Ankara

ZIP/Postal Code

06010

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32460989

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.

Results Reference

result

PubMed Identifier

34529156

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.

Results Reference

derived

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

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