NCT04583202

Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alyatec · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis
• Allergy to Pollen
• Rhinoconjunctivitis

Interventions

Type	Name	Description
OTHER	Exposure to placebo	Patients are exposed to a placebo for 4h in the Alyatec EEC
OTHER	Exposure to allergen	Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC

Timeline

• Start date: 2020-02-24
• Primary completion: 2020-10-19
• Completion: 2021-05-31
• First posted: 2020-10-12
• Last updated: 2021-06-09

Locations

1 site across 1 country: France