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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
provocative nasal test with grass pollen and nasal lavage
Change in concentration of IL-13 in the nasal lavage will be assessed
measurement by ELISA
Time frame: measurements at day 1 and day 30
Change in concentration of IL-5 in the nasal lavage will be assessed
Measurement by ELISA
Time frame: Day1 and Day30
Change in concentration of IL-4 in the nasal lavage will be assessed
Measurement by ELISA
Time frame: Day1 and Day 30
Change in Nasal Inspiratory Peak Flow will be assessed
Measurement with a peak flow meter
Time frame: Day 1 and Day 30
Change in Allergic Rhinitis Control test (ARCT) will be assessed
5 questions questionnaire score from 0 to 25 (0 worse score), 25 (best score)
Time frame: Day 1 and day 2
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