NCT04700852|Unknown
Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis
EPPNS
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EPPNS
Sponsor study identifier
interventional
15
0 countries
N/A
Study Start
February 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2020
Actual (reported)January 8, 2021
Actual (reported)February 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in concentration of IL-13 in the nasal lavage will be assessed
measurement by ELISA
measurements at day 1 and day 30
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
Puressentiel protective nasal spray
provocative nasal test with grass pollen and nasal lavage
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
November 10, 2020
First Posted
January 8, 2021
Study Start
February 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 31, 2021
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 8, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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