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

NCT02729012 | Completed Phase 4

• 1 other identifier: -11/2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Allergic Rhinitis

Keywords

Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nasal cytology pattern

  28 days

Study Arms (2)

Case

ACTIVE COMPARATOR

Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)

Drug: hypertonic saline solution (NACL 3%+NAHCO3)

Control

PLACEBO COMPARATOR

Allergic Rhinitis Children treated with saline solution (NACL 0,9%)

Other: Saline Solution (NACL 0,9%)

Interventions

hypertonic saline solution (NACL 3%+NAHCO3) DRUG

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

Case

Saline Solution (NACL 0,9%) OTHER

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

Control

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical history of Allergic Rhinitis (for at least 1 year)
• years old ≤ children age ≤ 14 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

Study Sites (1)

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

Palermo, Sicily, 90146, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Saline Solution, Hypertonic; Sodium Bicarbonate; Saline Solution

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Stefania La Grutta, MD

  IBIM,CNR, PALERMO, ITALY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: April 6, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)