Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700852
Recruitment Status : Not yet recruiting
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Puressentiel

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Due to Grass Pollen Allergic Inflammation Device: Puressentiel protective nasal spray Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in concentration of IL-5 in the nasal lavage will be assessed [ Time Frame: Day1 and Day30 ]
    Measurement by ELISA

  2. Change in concentration of IL-4 in the nasal lavage will be assessed [ Time Frame: Day1 and Day 30 ]
    Measurement by ELISA

  3. Change in Nasal Inspiratory Peak Flow will be assessed [ Time Frame: Day 1 and Day 30 ]
    Measurement with a peak flow meter

  4. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04700852


Contacts
Layout table for location contacts
Contact: Davide Caimmi, MD 33630061134 davide.caimmi@gmail.com
Contact: Elisabeth Simon, PhD 33144405528 e.simon@puressentiel.com

Sponsors and Collaborators
Puressentiel
Institut National de la Santé Et de la Recherche Médicale, France
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Puressentiel
ClinicalTrials.gov Identifier: NCT04700852    
Other Study ID Numbers: 2020-A01877-32
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Rhinitis, Allergic
Inflammation
Pathologic Processes
Respiratory Tract Infections
Infections
Nose Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases