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
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring nasal irrigation, allergic rhinitis, children
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
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
NCT ID
NCT01441778
First Posted
September 21, 2011
Last Updated
September 27, 2011
Sponsor
Thammasat University
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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