Allergic Rhinitis
Conditions
Keywords
nasal irrigation, allergic rhinitis, children
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 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
Interventions
DRUGNSS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
DRUGBHS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Outcome results
None listed