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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

  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

Sponsor: Thammasat University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Thammasat University

Dates:
Date Received: September 21, 2011
Date Started: June 2010
Date Completion:
Last Updated: September 27, 2011
Last Verified: September 2011