Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03963076

Acronym

ENAPAR

Enrollment

Registered

2019-05-24

Start date

2019-05-01

Completion date

2019-10-31

Last updated

2019-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Brief summary

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

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

Interventions

OTHERnasal 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

prospective multicentric study

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* allergic rhinitis with nasal obstruction

Exclusion criteria

* pregnant patients * patients with severe asthma

Design outcomes

Primary

Measure	Time frame	Description
Rhinitis auto questionnaire symptoms	Measurement at Day 0	5 questions quoted from 1 (worse) to 5 (best).

Secondary

Measure	Time frame	Description
Nasal inspiratory peak flow	Measurement at Day 0 and Day 30	Inspiratory nasal peak flow

Countries

France

Contacts

Primary Contactpascal Demoly, MD, PhD

pascal.demoly@inserm.fr33675034090

Backup ContactCaroline Bonnard, PhD

c.bonnard@puressentiel.com33180489432

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026