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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
NSS nasal irrigation salt
BHS nasal irrigation salt
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring nasal irrigation, allergic rhinitis, children

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Araya Satdabudha

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NSS irrigation salt

BHS nasal irrigaiton salt

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2011
Last Updated
September 27, 2011
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT01441778
Brief Title
Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children
Official Title
Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
nasal irrigation, allergic rhinitis, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NSS irrigation salt
Arm Type
Active Comparator
Arm Title
BHS nasal irrigaiton salt
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NSS nasal irrigation salt
Other Intervention Name(s)
NORMALINE
Intervention Description
nasal irrigation twice daily for 4 weeks period
Intervention Type
Drug
Intervention Name(s)
BHS nasal irrigation salt
Other Intervention Name(s)
SEANIS
Intervention Description
nasal irrigation twice daily for 4 weeks period
Primary Outcome Measure Information:
Title
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
Description
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 Outcome Measure Information:
Title
The effect of BHS and NSS on clinical effectiveness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 6-15 years diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology TNSS ≥ 4 at the first visit of this study Exclusion Criteria: Patients with a history of nasal anatomical defects Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araya Satdhabudh, MD
Organizational Affiliation
Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Araya Satdabudha
City
Klong luang
State/Province
Pratumthanee
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

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

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