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

Allergic Rhinitis Clinical Trial

— RinASol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729012
• Other study ID #: -11/2014
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2016
• Last updated: January 11, 2017
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Inflammation
• Rhinitis
• Rhinitis, Allergic

Intervention

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%)

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	28 days	No