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

This study has been completed.
Information provided by (Responsible Party):
araya satdhabudha, Thammasat University Identifier:
First received: September 21, 2011
Last updated: September 27, 2011
Last verified: September 2011
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.

Condition Intervention Phase
Allergic Rhinitis
Drug: NSS nasal irrigation salt
Drug: BHS nasal irrigation salt
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.

Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Enrollment: 81
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NSS irrigation salt Drug: NSS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
Experimental: BHS nasal irrigaiton salt Drug: BHS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
Other Name: SEANIS

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

Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01441778

Araya Satdabudha
Klong luang, Pratumthanee, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Principal Investigator: Araya Satdhabudh, MD Thammasat University
  More Information

Responsible Party: araya satdhabudha, clinical professor, Thammasat University Identifier: NCT01441778     History of Changes
Other Study ID Numbers: MTU-PE-2-CR038-038/53
14/2553 ( Other Grant/Funding Number: Thammasat research grant )
Study First Received: September 21, 2011
Last Updated: September 27, 2011

Keywords provided by Thammasat University:
nasal irrigation
allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 26, 2017