Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis (EPPNS)

January 7, 2021 updated by: Puressentiel

Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis

This study is a proof o concept aiming to determine the efficacy of Puressentiel nasal protective spray (PNPS) in patients with allergic rhinitis.

Cross over study, with a nasal provocative test (NPT) in patients with allergic rhinitis sensitized to grass pollen. A day 0 (first NPT) the following outcomes are recorded: allergic Rhinitis control test (ARCT) and Inspiratory nasal peak flow (INPF) before and 30 min after the NPT. Nasal lavage is performed 30 min after the NPT and 3 cytokines (IL4, IL5 and IL13 are measured by ELISA.

An other NPT is performed at day 30 and the same outcomes measured.

30 min before NPT 2 nasal sprays of PNPS are administered in each nostril in a randomized manner and cross over, the patient being is own control.

The primary outcomes ins the IL4, IL5 and IL13 concentrations in the nasal lavage. ARCT and INPF are the secondary outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

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

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma

Exclusion Criteria:

  • patients sensitized to a perrianual allergen
  • patients with viral infection 4 weeks before inclusion
  • patients with severe non controlled asthma
  • patients with chronic sinusitis
  • pregnancy or breast feeding
  • patients with hypersensitivity to essential oil (eucalyptus radie)
  • epileptic patient
  • patients treated with nasal corticosteroid or anti-histamine

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: allergic rhinitis
Puressentiel protective nasal spray
Device: Puressentiel protective nasal spray
provocative nasal test with grass pollen and nasal lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in concentration of IL-13 in the nasal lavage will be assessed
Time Frame: measurements at day 1 and day 30
measurement by ELISA
measurements at day 1 and day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in concentration of IL-5 in the nasal lavage will be assessed
Time Frame: Day1 and Day30
Measurement by ELISA
Day1 and Day30
Change in concentration of IL-4 in the nasal lavage will be assessed
Time Frame: Day1 and Day 30
Measurement by ELISA
Day1 and Day 30
Change in Nasal Inspiratory Peak Flow will be assessed
Time Frame: Day 1 and Day 30
Measurement with a peak flow meter
Day 1 and Day 30
Change in Allergic Rhinitis Control test (ARCT) will be assessed
Time Frame: Day 1 and day 2
5 questions questionnaire score from 0 to 25 (0 worse score), 25 (best score)
Day 1 and day 2

Collaborators and Investigators

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

Sponsor

Puressentiel

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

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 (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01877-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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