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

May 23, 2019 updated by: Puressentiel

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • allergic rhinitis with nasal obstruction

Exclusion Criteria:

  • pregnant patients
  • patients with severe asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinitis auto questionnaire symptoms
Time Frame: Measurement at Day 0
5 questions quoted from 1 (worse) to 5 (best).
Measurement at Day 0
Rhinitis auto questionnaire symptoms
Time Frame: Measurement at Day 30
5 questions quoted from 1 (worse) to 5 (best).
Measurement at Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal inspiratory peak flow
Time Frame: Measurement at Day 0 and Day 30
Inspiratory nasal peak flow
Measurement at Day 0 and Day 30
Nasal inspiratory peak flow
Time Frame: Measurement at Day 30
Inspiratory nasal peak flow
Measurement at Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puressentiel

Collaborators

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

October 31, 2019

Study Registration Dates

First Submitted

May 18, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Puressentiel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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