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

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ClinicalTrials.gov Identifier: NCT03963076
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
University Hospital, Montpellier
Information provided by (Responsible Party):
Puressentiel

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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Other: nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli) Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective multicentric study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: allergic rhinitis
administration of a nasal hypertonic spray twice a day for one month
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




Primary Outcome Measures :
  1. Rhinitis auto questionnaire symptoms [ Time Frame: Measurement at Day 0 ]
    5 questions quoted from 1 (worse) to 5 (best).

  2. Rhinitis auto questionnaire symptoms [ Time Frame: Measurement at Day 30 ]
    5 questions quoted from 1 (worse) to 5 (best).


Secondary Outcome Measures :
  1. Nasal inspiratory peak flow [ Time Frame: Measurement at Day 0 and Day 30 ]
    Inspiratory nasal peak flow

  2. Nasal inspiratory peak flow [ Time Frame: Measurement at Day 30 ]
    Inspiratory nasal peak flow



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • allergic rhinitis with nasal obstruction

Exclusion Criteria:

  • pregnant patients
  • patients with severe asthma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963076


Contacts
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Contact: pascal Demoly, MD, PhD 33675034090 pascal.demoly@inserm.fr
Contact: Caroline Bonnard, PhD 33180489432 c.bonnard@puressentiel.com

Locations
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France
Caroline Bonnard Recruiting
Paris, France, 75016
Contact: Pascal Demoly    33675034090    pascal.demoly@inserm.fr   
Sponsors and Collaborators
Puressentiel
University Hospital, Montpellier

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Responsible Party: Puressentiel
ClinicalTrials.gov Identifier: NCT03963076     History of Changes
Other Study ID Numbers: Puressentiel
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases