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

Allergic Rhinitis Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

• NCT number: NCT01441778
• Study type: Interventional
• Source: Thammasat University
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Completion date: December 2010