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

Thammasat University81 enrolled

Overview

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.

1. 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. 2. 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 1. total nasal symptom score(TNSS) 2. satisfaction to nasal irrigation 3. side effect * at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation 1. quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient) 2. medication use to relieve AR symptom(from diary record) 3. compliance for nasal irrigation (from diary record) 4. side effect (from diary record) 5. overall satisfaction to nasal irrigation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

NSS nasal irrigation saltDRUG

nasal irrigation twice daily for 4 weeks period

BHS nasal irrigation saltDRUG

nasal irrigation twice daily for 4 weeks period

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. age 6-15 years 2. diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology 3. TNSS ≥ 4 at the first visit of this study Exclusion Criteria: 1. Patients with a history of nasal anatomical defects 2. Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks

Locations (1)

Araya Satdabudha

Klong Luang, Pratumthanee, Thailand

Outcomes

Primary Outcomes

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.

Time frame: baseline, 10 minute after nasal irrigaiton

Secondary Outcomes

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

Time frame: 1st visit, 2nd week and 4 week follow up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.