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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: NSS nasal irrigation salt; Drug: BHS nasal irrigation salt

• Registration Number: NCT01441778
• Lead Sponsor: Thammasat University

Brief 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

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Status Verified: 2011-09
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-27
• Last Update Submitted: 2011-09-27
• Study First Posted: 2011-09-28
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSS irrigation salt	NSS nasal irrigation salt	-
BHS nasal irrigaiton salt	BHS nasal irrigation salt	-

Primary Outcome Measures

Name	Time	Method
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS	baseline, 10 minute after nasal irrigaiton	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Araya Satdabudha; 🇹🇭 Klong luang, Pratumthanee, Thailand