Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

Study Overview
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Brief Summary
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This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis. Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA. An other NPT is performed at day 30 and the same outcomes measured. 30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control. The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.

Official Title
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Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis

Conditions
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Allergic Rhinitis Due to Grass Pollen, Allergic Inflammation

Intervention / Treatment
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* Device: Puressentiel protective nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma Exclusion Criteria: patients sensitized to a perrianual allergen patients with viral infection 4 weeks before inclusion patients with severe non controlled asthma patients with chronic sinusitis pregnancy or breast feeding patients with hypersensitivity to essential oil (eucalyptus radie) epileptic patient patients treated with nasal corticosteroid or anti-histamine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: allergic rhinitis<br>Puressentiel protective nasal spray | Device: Puressentiel protective nasal spray<br>* provocative nasal test with grass pollen and nasal lavage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of IL-13 in the nasal lavage will be assessed | measurement by ELISA | measurements at day 1 and day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of IL-5 in the nasal lavage will be assessed | Measurement by ELISA | Day1 and Day30 | 
| Change in concentration of IL-4 in the nasal lavage will be assessed | Measurement by ELISA | Day1 and Day 30 | 
| Change in Nasal Inspiratory Peak Flow will be assessed | Measurement with a peak flow meter | Day 1 and Day 30 | 
| Change in Allergic Rhinitis Control test (ARCT) will be assessed | 5 questions questionnaire score from 0 to 25 (0 worse score), 25 (best score) | Day 1 and day 2 |