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

Puressentiel

Status: Unknown

Conditions: Allergic Rhinitis Due to Grass Pollen; Allergic Inflammation

Treatments: Device: Puressentiel protective nasal spray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04700852

2020-A01877-32

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

allergic rhinitis

Experimental group

Description:

Puressentiel protective nasal spray

Treatment:

Device: Puressentiel protective nasal spray