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| Name | Class |
|---|---|
| University Hospital, Montpellier | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allergic rhinitis | Experimental | administration of a nasal hypertonic spray twice a day for one month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli) | Other | One spray of nasal hypertonic spray morning and evening every day during 30 days |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| pascal Demoly, MD, PhD | Contact | 33675034090 | pascal.demoly@inserm.fr | |
| Caroline Bonnard, PhD | Contact | 33180489432 | c.bonnard@puressentiel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caroline Bonnard | Recruiting | Paris | 75016 | France |
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prospective multicentric study
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| Measurement at Day 30 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009822 | Oils, Volatile |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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