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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stefania La Grutta, MD
• Treatments: Pharmaceutical Solutions

Criteria

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.