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

Thammasat University

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: BHS nasal irrigation salt; Drug: NSS nasal irrigation salt

Study type: Interventional

Funder types: Other

Identifiers

NCT01441778

MTU-PE-2-CR038-038/53

14/2553 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 81 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups

NSS irrigation salt

Active Comparator group

Treatment:

Drug: NSS nasal irrigation salt

BHS nasal irrigaiton salt

Experimental group

Treatment:

Drug: BHS nasal irrigation salt