Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

Study Overview
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Brief Summary
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Prospective multicentric study. 60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow. Subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days. Rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.

Detailed Description
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Objective: evaluate the efficiency of a nasal hypertonic spray Puressentiel in subjects with allergic rhinitis and nasal obstruction. Inclusion criteria: subjects with allergic obstructive rhinitis without treatment or remaining symptomatic despite treatment. Duration of exposure: 2 nasal sprays per day (morning and evening) during 30 months. Primary criteria of efficacy: Rhinitis questionnaire. Secondary criteria: Inspiratory nasal peak flow

Official Title
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Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: allergic rhinitis with nasal obstruction Exclusion Criteria: pregnant patients patients with severe asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective multicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: allergic rhinitis<br>administration of a nasal hypertonic spray twice a day for one month | Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)<br>* One spray of nasal hypertonic spray morning and evening every day during 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinitis auto questionnaire symptoms | 5 questions quoted from 1 (worse) to 5 (best). | Measurement at Day 0 | 
| Rhinitis auto questionnaire symptoms | 5 questions quoted from 1 (worse) to 5 (best). | Measurement at Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal inspiratory peak flow | Inspiratory nasal peak flow | Measurement at Day 0 and Day 30 | 
| Nasal inspiratory peak flow | Inspiratory nasal peak flow | Measurement at Day 30 |