Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

Allergic Rhinitis Clinical Trial

— ENAPAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963076
• Other study ID #: Puressentiel
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2019
• Source: Puressentiel
• Contact: pascal Demoly, MD, PhD
• Phone: 33675034090
• Email: pascal.demoly[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• allergic rhinitis with nasal obstruction

Exclusion Criteria:

• pregnant patients

• patients with severe asthma

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Caroline Bonnard	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Puressentiel	University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinitis auto questionnaire symptoms	5 questions quoted from 1 (worse) to 5 (best).	Measurement at Day 0
Primary	Rhinitis auto questionnaire symptoms	5 questions quoted from 1 (worse) to 5 (best).	Measurement at Day 30
Secondary	Nasal inspiratory peak flow	Inspiratory nasal peak flow	Measurement at Day 0 and Day 30
Secondary	Nasal inspiratory peak flow	Inspiratory nasal peak flow	Measurement at Day 30