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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
araya satdhabudha, Thammasat University
ClinicalTrials.gov Identifier:
NCT01441778
First received: September 21, 2011
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Dietary Sodium
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Other Name: NORMALINE
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
  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441778

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

No publications provided

Responsible Party: araya satdhabudha, clinical professor, Thammasat University
ClinicalTrials.gov Identifier: NCT01441778     History of Changes
Other Study ID Numbers: MTU-PE-2-CR038-038/53, 14/2553
Study First Received: September 21, 2011
Last Updated: September 27, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Thammasat University:
nasal irrigation
allergic rhinitis
children

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013