Allergic Rhinitis
Conditions
Keywords
Children
Brief summary
The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology. The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)
Interventions
DRUGhypertonic saline solution (NACL 3%+NAHCO3)
Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)
Treatment with nebulized Saline Solution (NACL 0,9%)
Sponsors
Stefania La Grutta, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Clinical history of Allergic Rhinitis (for at least 1 year) * 6 years old ≤ children age ≤ 14 years old * Total Symptom Score 5: \>5 in the last 4 days before screening.
Exclusion criteria
* Signs of acute infections of upper and lower respiratory tract. * Metabolic, immunological, systemic diseases * Respiratory tract deformity * Systemic/Topical therapies with antibiotics or corticosteroids in the previous 30 days. * Active smoker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom score assessment | 28 days | The main objective is to evaluate the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on the symptom score assessed by T5SS Questionnaire (Total Symptom Score 5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal cytology pattern | 28 days | The secondary objective is to evaluate the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation, in patients with seasonal Allergic Rhinitis, by means of nasal cytology. |
Countries
Italy
Outcome results
None listed