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

NCT ID: NCT01441778

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-12-31

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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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

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NSS irrigation salt

Group Type ACTIVE_COMPARATOR

NSS nasal irrigation salt

Intervention Type DRUG

nasal irrigation twice daily for 4 weeks period

BHS nasal irrigaiton salt

Group Type EXPERIMENTAL

BHS nasal irrigation salt

Intervention Type DRUG

nasal irrigation twice daily for 4 weeks period

Interventions

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NSS nasal irrigation salt

nasal irrigation twice daily for 4 weeks period

Intervention Type DRUG

BHS nasal irrigation salt

nasal irrigation twice daily for 4 weeks period

Intervention Type DRUG

Other Intervention Names

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NORMALINE SEANIS

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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araya satdhabudha

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Araya Satdhabudh, MD

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

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Araya Satdabudha

Klong Luang, Pratumthanee, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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14/2553

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MTU-PE-2-CR038-038/53

Identifier Type: -

Identifier Source: org_study_id