Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

NCT ID: NCT03963076

Last Updated: 2019-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-10-31

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

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective multicentric study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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allergic rhinitis

administration of a nasal hypertonic spray twice a day for one month

Group Type EXPERIMENTAL

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

Intervention Type OTHER

One spray of nasal hypertonic spray morning and evening every day during 30 days

Interventions

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

One spray of nasal hypertonic spray morning and evening every day during 30 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* allergic rhinitis with nasal obstruction

Exclusion Criteria

* pregnant patients
* patients with severe asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Puressentiel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caroline Bonnard

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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pascal Demoly, MD, PhD

Role: CONTACT

33675034090

Caroline Bonnard, PhD

Role: CONTACT

33180489432

Facility Contacts

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Pascal Demoly

Role: primary

33675034090

Other Identifiers

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Puressentiel

Identifier Type: -

Identifier Source: org_study_id

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