Back to resultsEffects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study (RinASol)
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
hypertonic saline solution (NACL 3%+NAHCO3)
Saline Solution (NACL 0,9%)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Children
Eligibility 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.
Sites / Locations
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Case
Control
Arm Description
Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)
Allergic Rhinitis Children treated with saline solution (NACL 0,9%)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02729012
Brief Title
Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stefania La Grutta, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case
Arm Type
Active Comparator
Arm Description
Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Allergic Rhinitis Children treated with saline solution (NACL 0,9%)
Intervention Type
Drug
Intervention Name(s)
hypertonic saline solution (NACL 3%+NAHCO3)
Intervention Description
Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)
Intervention Type
Other
Intervention Name(s)
Saline Solution (NACL 0,9%)
Intervention Description
Treatment with nebulized Saline Solution (NACL 0,9%)
Primary Outcome Measure Information:
Title
Symptom score assessment
Description
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)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Nasal cytology pattern
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefania La Grutta, MD
Organizational Affiliation
IBIM,CNR, PALERMO, ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
City
Palermo
State/Province
Sicily
ZIP/Postal Code
90146
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study
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