Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

NCT ID: NCT04700852

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis Due to Grass Pollen Allergic Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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allergic rhinitis

Puressentiel protective nasal spray

Group Type EXPERIMENTAL

Puressentiel protective nasal spray

Intervention Type DEVICE

provocative nasal test with grass pollen and nasal lavage

Interventions

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Puressentiel protective nasal spray

provocative nasal test with grass pollen and nasal lavage

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Puressentiel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Davide Caimmi, MD

Role: CONTACT

33630061134

Elisabeth Simon, PhD

Role: CONTACT

33144405528

Other Identifiers

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2020-A01877-32

Identifier Type: -

Identifier Source: org_study_id

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