NCT04700852

Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

Efficacy of Puressentiel Protective Nasal Spray on Symptoms and Inflammation in Patients With in Allergic Rhinitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Puressentiel · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis Due to Grass Pollen
• Allergic Inflammation

Interventions

Type	Name	Description
DEVICE	Puressentiel protective nasal spray	provocative nasal test with grass pollen and nasal lavage

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-07-31
• Completion: 2021-09-30
• First posted: 2021-01-08
• Last updated: 2021-01-08