Efficacy of Puressentiel Protective Nasal Spray in Allerg... | NCT04700852

Studies
Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

NCT04700852

Sponsor

Puressentiel

Status

Unknown status

Last Update Posted

Jan 8, 2021Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Allergic Rhinitis Due to Grass Pollen
Allergic Inflammation

Interventions

Puressentiel protective nasal spray

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Jul 31, 2021Estimated

Completion Date

Sep 30, 2021Estimated

First Submitted Date

Nov 10, 2020

First Submission Date that Met QC Criteria

Jan 7, 2021

First Posted Date

Jan 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2021

Last Update Posted Date

Jan 8, 2021Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
allergic rhinitis	Experimental	Puressentiel protective nasal spray	Device: Puressentiel protective nasal spray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Puressentiel protective nasal spray	Device	provocative nasal test with grass pollen and nasal lavage	allergic rhinitis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in concentration of IL-5 in the nasal lavage will be assessed	Measurement by ELISA	Day1 and Day30
Change in concentration of IL-4 in the nasal lavage will be assessed	Measurement by ELISA

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Davide Caimmi, MD	Contact	33630061134		davide.caimmi@gmail.com
Elisabeth Simon, PhD	Contact	33144405528		e.simon@puressentiel.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided