Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis

Allergic Rhinitis Due to Grass Pollen Clinical Trial

— EPPNS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04700852
• Other study ID #: 2020-A01877-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2021
• Source: Puressentiel
• Contact: Davide Caimmi, MD
• Phone: 33630061134
• Email: davide.caimmi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Inflammation
• Allergic Rhinitis Due to Grass Pollen
• Inflammation
• Rhinitis
• Rhinitis, Allergic

Intervention

Device:
• Puressentiel protective nasal spray
provocative nasal test with grass pollen and nasal lavage

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Puressentiel	Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in concentration of IL-13 in the nasal lavage will be assessed	measurement by ELISA	measurements at day 1 and day 30
Secondary	Change in concentration of IL-5 in the nasal lavage will be assessed	Measurement by ELISA	Day1 and Day30
Secondary	Change in concentration of IL-4 in the nasal lavage will be assessed	Measurement by ELISA	Day1 and Day 30
Secondary	Change in Nasal Inspiratory Peak Flow will be assessed	Measurement with a peak flow meter	Day 1 and Day 30
Secondary	Change in Allergic Rhinitis Control test (ARCT) will be assessed	5 questions questionnaire score from 0 to 25 (0 worse score), 25 (best score)	Day 1 and day 2