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

Sponsor
Thammasat University (Other)
Overall Status
Completed
CT.gov ID
NCT01441778
Collaborator
(none)
81
Enrollment
1
Location
2
Arms
6
Duration (Months)
13.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NSS nasal irrigation salt
  • Drug: BHS nasal irrigation salt
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (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.
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS [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

    1. The effect of BHS and NSS on clinical effectiveness [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    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

    Locations

    Site City State Country Postal Code
    1 Araya Satdabudha Klong luang Pratumthanee Thailand 12120

    Sponsors and Collaborators

    • Thammasat University

    Investigators

    • Principal Investigator: Araya Satdhabudh, MD, Thammasat University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    araya satdhabudha, clinical professor, Thammasat University
    ClinicalTrials.gov Identifier:
    NCT01441778
    Other Study ID Numbers:
    • MTU-PE-2-CR038-038/53
    • 14/2553
    First Posted:
    Sep 28, 2011
    Last Update Posted:
    Sep 28, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by araya satdhabudha, clinical professor, Thammasat University
    nasal irrigation
    allergic rhinitis
    children
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic

    Study Results

    No Results Posted as of Sep 28, 2011