Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study

Study Overview
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Brief Summary
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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)

Official Title
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Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With Allergic Rhinitis. RinASol- Pilot Study (Allergic Rhinitis Solution)

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: hypertonic saline solution (NACL 3%+NAHCO3)
* Other: Saline Solution (NACL 0,9%)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case<br>Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3) | Drug: hypertonic saline solution (NACL 3%+NAHCO3)<br>* Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)<br>|
| Placebo Comparator: Control<br>Allergic Rhinitis Children treated with saline solution (NACL 0,9%) | Other: Saline Solution (NACL 0,9%)<br>* Treatment with nebulized Saline Solution (NACL 0,9%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score assessment | 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) | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal cytology pattern | 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. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children