Allergic Rhinitis Clinical Trial
— RinASolOfficial title:
Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With Allergic Rhinitis. RinASol- Pilot Study (Allergic Rhinitis Solution)
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)
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily |
Lead Sponsor | Collaborator |
---|---|
Stefania La Grutta, MD |
Italy,
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 |
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