Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis
EPPNS
1 other identifier
interventional
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 8, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJanuary 8, 2021
January 1, 2021
6 months
November 10, 2020
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in concentration of IL-13 in the nasal lavage will be assessed
measurement by ELISA
measurements at day 1 and day 30
Secondary Outcomes (4)
Change in concentration of IL-5 in the nasal lavage will be assessed
Day1 and Day30
Change in concentration of IL-4 in the nasal lavage will be assessed
Day1 and Day 30
Change in Nasal Inspiratory Peak Flow will be assessed
Day 1 and Day 30
Change in Allergic Rhinitis Control test (ARCT) will be assessed
Day 1 and day 2
Study Arms (1)
allergic rhinitis
EXPERIMENTALPuressentiel protective nasal spray
Interventions
provocative nasal test with grass pollen and nasal lavage
Eligibility Criteria
You may qualify if:
- patients with diagnostic of allergic rhinitis sensitized to grass pollen for more than one year with or without associated asthma
You may not qualify if:
- patients sensitized to a perrianual allergen
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2020
First Posted
January 8, 2021
Study Start
February 1, 2021
Primary Completion
July 31, 2021
Study Completion
September 30, 2021
Last Updated
January 8, 2021
Record last verified: 2021-01