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

NCT02729012 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-12

No results posted yet for this study

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)

Conditions

  • Allergic Rhinitis

Interventions

DRUG

hypertonic saline solution (NACL 3%+NAHCO3)

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

OTHER

Saline Solution (NACL 0,9%)

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

Sponsors & Collaborators

  • Stefania La Grutta, MD

    lead OTHER

Principal Investigators

  • Stefania La Grutta, MD · IBIM,CNR, PALERMO, ITALY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02729012 on ClinicalTrials.gov