Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.

Detailed Description
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BHS is superior to NSS for improving mucociliary function that by measure saccharine clearance time(SCT)at 10 minute after nasal irrigation compare to baseline. BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up at short period: compare the following results at baseline and 10 minute after nasal irrigation total nasal symptom score(TNSS) satisfaction to nasal irrigation side effect at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient) medication use to relieve AR symptom(from diary record) compliance for nasal irrigation (from diary record) side effect (from diary record) overall satisfaction to nasal irrigation

Official Title
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Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: NSS nasal irrigation salt
* Drug: BHS nasal irrigation salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 6-15 years diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology TNSS ≥ 4 at the first visit of this study Exclusion Criteria: Patients with a history of nasal anatomical defects Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSS irrigation salt<br> | Drug: NSS nasal irrigation salt<br>* nasal irrigation twice daily for 4 weeks period<br>* Other names: NORMALINE;|
| Experimental: BHS nasal irrigaiton salt<br> | Drug: BHS nasal irrigation salt<br>* nasal irrigation twice daily for 4 weeks period<br>* Other names: SEANIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS | SCT method : subjects seated with their head upright. A rhinoprobe was used to place a small piece of saccharine on the medial aspect of the inferior turbinate approximately 1 cm, posterior to the nasal vestibule. The SCT was recorded as the subject's first perception of a sweet taste. | baseline, 10 minute after nasal irrigaiton | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of BHS and NSS on clinical effectiveness | evaluate total nasal symptom score, side effect, satisfaction for nasal irrigation, quality of life at 1st visit, 2nd week and 4 week follow up | 1st visit, 2nd week and 4 week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal irrigation, allergic rhinitis, children