Allergic Inflammation, Allergic Rhinitis Due to Grass Pollen
Conditions
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.
Interventions
DEVICEPuressentiel protective nasal spray
provocative nasal test with grass pollen and nasal lavage
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Puressentiel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in concentration of IL-13 in the nasal lavage will be assessed | measurements at day 1 and day 30 | measurement by ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in concentration of IL-5 in the nasal lavage will be assessed | Day1 and Day30 | Measurement by ELISA |
| Change in concentration of IL-4 in the nasal lavage will be assessed | Day1 and Day 30 | Measurement by ELISA |
| Change in Nasal Inspiratory Peak Flow will be assessed | Day 1 and Day 30 | Measurement with a peak flow meter |
| Change in Allergic Rhinitis Control test (ARCT) will be assessed | Day 1 and day 2 | 5 questions questionnaire score from 0 to 25 (0 worse score), 25 (best score) |
Contacts
Primary ContactDavide Caimmi, MD
Backup ContactElisabeth Simon, PhD
Outcome results
None listed