Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

Not Applicable

• Conditions: Allergic Rhinitis Due to Grass Pollen; Allergic Inflammation
• Interventions: Device: Puressentiel protective nasal spray

• Registration Number: NCT04700852
• Lead Sponsor: Puressentiel

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 available

Study Timeline

• Study First Submitted: 2020-11-10
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Study Start: 2021-02-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
allergic rhinitis	Puressentiel protective nasal spray	Puressentiel protective nasal spray

Primary Outcome Measures

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

Secondary Outcome Measures

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