Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583202
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2020-09-30
Brief Title:
Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
Sponsor:
Alyatec
Organization:
Alyatec
Study Overview
Official Title:
Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to assess the nasal and conjunctival response in subjects allergic to birch pollen during controlled exposures in the ALYATEC environmental exposure chamber EEC
Detailed Description:
This is a single-center single-blind placebo-controlled study The first part of the study consists of 6 exposure sessions in Alyatec EEC including placebo and birch pollen allergen exposures
The second part of the study involves in-field evaluations of rhinitis and conjunctivitis symptoms during birch pollen season
Alyatec environmental exposure chamber also called allergen challenge chamber allows to evaluate allergic symptoms in standardized and reproducible conditions All the metrological parameters temperature air flow hygrometry are controlled as well as the allergen concentration diffused in the room
This enables to induce and observe rhinitis conjunctivitis and asthma symptoms for up to 20 patients at the same time in a reproducible way and without the potential perturbations or contaminations of the natural environment
The current study aims to get specific information about allergic symptoms induced in the Alyatec EEC chamber in patients sensitized to birch pollen allergen
The second part of the study involves in-field evaluations of rhinitis and conjunctivitis symptoms during birch pollen season
Alyatec environmental exposure chamber also called allergen challenge chamber allows to evaluate allergic symptoms in standardized and reproducible conditions All the metrological parameters temperature air flow hygrometry are controlled as well as the allergen concentration diffused in the room
This enables to induce and observe rhinitis conjunctivitis and asthma symptoms for up to 20 patients at the same time in a reproducible way and without the potential perturbations or contaminations of the natural environment
The current study aims to get specific information about allergic symptoms induced in the Alyatec EEC chamber in patients sensitized to birch pollen allergen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None