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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Active Comparator | Allergic Rhinitis Children treated with hypertonic saline solution (NACL 3%+NAHCO3) |
|
| Control | Placebo Comparator | Allergic Rhinitis Children treated with saline solution (NACL 0,9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypertonic saline solution (NACL 3%+NAHCO3) | Drug | Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefania La Grutta, MD | IBIM,CNR, PALERMO, ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily | 90146 | Italy |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D017693 | Sodium Bicarbonate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D001639 | Bicarbonates |
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| Saline Solution (NACL 0,9%) | Other | Treatment with nebulized Saline Solution (NACL 0,9%) |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002254 |
| Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |