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Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis (ENAPAR)

Primary Purpose

Allergic Rhinitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)
Sponsored by
Puressentiel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • allergic rhinitis with nasal obstruction

Exclusion Criteria:

  • pregnant patients
  • patients with severe asthma

Sites / Locations

  • Caroline BonnardRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

allergic rhinitis

Arm Description

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

Outcomes

Primary Outcome Measures

Rhinitis auto questionnaire symptoms
5 questions quoted from 1 (worse) to 5 (best).
Rhinitis auto questionnaire symptoms
5 questions quoted from 1 (worse) to 5 (best).

Secondary Outcome Measures

Nasal inspiratory peak flow
Inspiratory nasal peak flow
Nasal inspiratory peak flow
Inspiratory nasal peak flow

Full Information

First Posted
May 18, 2019
Last Updated
May 23, 2019
Sponsor
Puressentiel
Collaborators
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03963076
Brief Title
Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis
Acronym
ENAPAR
Official Title
Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Puressentiel
Collaborators
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective multicentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
allergic rhinitis
Arm Type
Experimental
Arm Description
administration of a nasal hypertonic spray twice a day for one month
Intervention Type
Other
Intervention Name(s)
nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)
Intervention Description
One spray of nasal hypertonic spray morning and evening every day during 30 days
Primary Outcome Measure Information:
Title
Rhinitis auto questionnaire symptoms
Description
5 questions quoted from 1 (worse) to 5 (best).
Time Frame
Measurement at Day 0
Title
Rhinitis auto questionnaire symptoms
Description
5 questions quoted from 1 (worse) to 5 (best).
Time Frame
Measurement at Day 30
Secondary Outcome Measure Information:
Title
Nasal inspiratory peak flow
Description
Inspiratory nasal peak flow
Time Frame
Measurement at Day 0 and Day 30
Title
Nasal inspiratory peak flow
Description
Inspiratory nasal peak flow
Time Frame
Measurement at Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: allergic rhinitis with nasal obstruction Exclusion Criteria: pregnant patients patients with severe asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
pascal Demoly, MD, PhD
Phone
33675034090
Email
pascal.demoly@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Bonnard, PhD
Phone
33180489432
Email
c.bonnard@puressentiel.com
Facility Information:
Facility Name
Caroline Bonnard
City
Paris
ZIP/Postal Code
75016
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Demoly
Phone
33675034090
Email
pascal.demoly@inserm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis

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