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

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ClinicalTrials.gov Identifier: NCT02729012
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

Study Description
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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)


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: hypertonic saline solution (NACL 3%+NAHCO3) Other: Saline Solution (NACL 0,9%) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Case
Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3)
 Drug: hypertonic saline solution (NACL 3%+NAHCO3)
Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)
Placebo Comparator: Control
Allergic Rhinitis Children treated with saline solution (NACL 0,9%)
 Other: Saline Solution (NACL 0,9%)
Treatment with nebulized Saline Solution (NACL 0,9%)


Outcome Measures
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Primary Outcome Measures :
  1. Symptom score assessment [ Time Frame: 28 days ]
    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 :
  1. Nasal cytology pattern [ Time Frame: 28 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729012


Locations
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Italy
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, Italy, 90146
Sponsors and Collaborators
Stefania La Grutta, MD
Investigators
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Principal Investigator: Stefania La Grutta, MD IBIM,CNR, PALERMO, ITALY
More Information
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Responsible Party: Stefania La Grutta, MD, 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., Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier: NCT02729012    
Other Study ID Numbers: -11/2014
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica:
Children
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Inflammation
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions