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

September 27, 2011 updated by: araya satdhabudha, Thammasat University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pratumthanee
      • Klong luang, Pratumthanee, Thailand, 12120
        • Araya Satdabudha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NSS irrigation salt
Drug: NSS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
Other Names:
  • NORMALINE
EXPERIMENTAL: BHS nasal irrigaiton salt
Drug: BHS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
Other Names:
  • SEANIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
Time Frame: 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.
baseline, 10 minute after nasal irrigaiton

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of BHS and NSS on clinical effectiveness
Time Frame: 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
1st visit, 2nd week and 4 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Araya Satdhabudh, MD, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (ESTIMATE)

September 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-PE-2-CR038-038/53
  • 14/2553 (OTHER_GRANT: Thammasat research grant)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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