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Completed

NCT Number: NCT01441778

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

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Araya Satdabudha

Klong Luang, Pratumthanee, 12120, Thailand

About this study

  • 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.
  • 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
  • total nasal symptom score(TNSS)
  • satisfaction to nasal irrigation
  • side effect
  • at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation
  • quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient)
  • medication use to relieve AR symptom(from diary record)
  • compliance for nasal irrigation (from diary record)
  • side effect (from diary record)
  • overall satisfaction to nasal irrigation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 6-15 years
  • diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology
  • TNSS ≥ 4 at the first visit of this study

Exclusion criteria

  • Patients with a history of nasal anatomical defects
  • Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks

Treatment and study plan

NSS nasal irrigation salt

Drug

nasal irrigation twice daily for 4 weeks period

Other names: NORMALINE

BHS nasal irrigation salt

Drug

nasal irrigation twice daily for 4 weeks period

Other names: SEANIS

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 28, 2011
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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