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

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: hypertonic saline solution (NACL 3%+NAHCO3); Other: Saline Solution (NACL 0,9%)

• Registration Number: NCT02729012
• Lead Sponsor: Stefania La Grutta, MD

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	hypertonic saline solution (NACL 3%+NAHCO3)	Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)
Control	Saline Solution (NACL 0,9%)	Allergic Rhinitis Children treated with saline solution (NACL 0,9%)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy