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

Stefania La Grutta, MD30 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergic Rhinitis

Interventions

hypertonic saline solution (NACL 3%+NAHCO3)DRUG

Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)

Saline Solution (NACL 0,9%)OTHER

Treatment with nebulized Saline Solution (NACL 0,9%)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, Italy

Outcomes

Primary Outcomes

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)

Time frame: 28 days

Secondary Outcomes

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.

Time frame: 28 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.