Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis
NCT ID: NCT04700852
Last Updated: 2021-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2021-02-01
2021-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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allergic rhinitis
Puressentiel protective nasal spray
Puressentiel protective nasal spray
provocative nasal test with grass pollen and nasal lavage
Interventions
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Puressentiel protective nasal spray
provocative nasal test with grass pollen and nasal lavage
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Puressentiel
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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2020-A01877-32
Identifier Type: -
Identifier Source: org_study_id
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