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Completed

NCT Number: NCT02729012

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

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)

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Key information

Conditions

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

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypertonic saline solution (NACL 3%+NAHCO3)

Drug

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

Saline Solution (NACL 0,9%)

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stefania La Grutta, MD

Other

Registry information

Official study title

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

Acronym: RinASol

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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