NCT01441778

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	NSS nasal irrigation salt	nasal irrigation twice daily for 4 weeks period
DRUG	BHS nasal irrigation salt	nasal irrigation twice daily for 4 weeks period

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-10-01
• Completion: 2010-12-01
• First posted: 2011-09-28
• Last updated: 2011-09-28

Locations

1 site across 1 country: Thailand