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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo exposure | Placebo Comparator | All patients undergo 2 placebo exposures |
|
| Birch Pollen Exposure | Experimental | All patients undergo 4 allergen exposures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to placebo | Other | Patients are exposed to a placebo for 4h in the Alyatec EEC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score | To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC. | 4 hours exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for rhinitis | To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC. | 4 hours exposure |
| Total Nasal Symptom Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric de Blay, Pr. | Alyatec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alyatec | Strasbourg | Grand Est | 67000 | France |
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| Label | URL |
|---|---|
| Alyatec website | View source |
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| Exposure to allergen |
| Other |
Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC |
|
To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
| 4 hours exposure |
| Visual Analogue Scale for conjunctivitis | To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC. | 4 hours exposure |
| Total Ocular Symptom Score | To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC. | 4 hours exposure |
| Peak Nasal Inspiratory Flow | To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC. | 4 hours exposure |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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