Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
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|ClinicalTrials.gov Identifier: NCT04583202|
Recruitment Status : Completed
First Posted : October 12, 2020
Last Update Posted : June 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Allergy to Pollen Rhinoconjunctivitis||Other: Exposure to placebo Other: Exposure to allergen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber|
|Actual Study Start Date :||February 24, 2020|
|Actual Primary Completion Date :||October 19, 2020|
|Actual Study Completion Date :||May 31, 2021|
Placebo Comparator: Placebo exposure
All patients undergo 2 placebo exposures
Other: Exposure to placebo
Patients are exposed to a placebo for 4h in the Alyatec EEC
Experimental: Birch Pollen Exposure
All patients undergo 4 allergen exposures
Other: Exposure to allergen
Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC
- Total Nasal Symptom Score [ Time Frame: 4 hours exposure ]To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
- Visual Analogue Scale for rhinitis [ Time Frame: 4 hours exposure ]To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
- Total Nasal Symptom Score [ Time Frame: 4 hours exposure ]To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
- Visual Analogue Scale for conjunctivitis [ Time Frame: 4 hours exposure ]To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
- Total Ocular Symptom Score [ Time Frame: 4 hours exposure ]To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
- Peak Nasal Inspiratory Flow [ Time Frame: 4 hours exposure ]To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- A clinical history of allergic rhinitis to birch pollen for at least 2 consecutive pollen seasons requiring the taking of a symptomatic drug with or without associated asthma
- Positive skin prick tests for birch pollen (> 3 mm)
- IgE specific to birch > 0.75 kUI / L.
- Positive unit rapid nasal provocation test for birch pollen
- Subjects having signed informed consent
- Subjects affiliated to a social security scheme
- Subjects able to understand and complete the procedures related to the study
- Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception
- Specific immunotherapy (SIT) for birch allergens for more than a month in the 3 years preceding the screening
- Current use of Specific immunotherapy for another allergen
- Medical history of anaphylaxis following exposure to birch pollen
- Medical history of anaphylaxis linked to another allergen in the last 6 weeks
- Nasal polyps, nasal septum deviation or diagnosis of non-allergic rhinitis
- Subjects allergic to indoor environmental allergens (cat allergens, mold, dust mites) with - Obvious exposure to these allergens.
- Uncontrolled allergic pathology (rhinitis, conjunctivitis)
- Forced expiratory volume in 1 second (FEV1) <70% of predicted normal values
- Moderate to severe asthma (GINA 3 to 5)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583202
|Strasbourg, Grand Est, France, 67000|
|Principal Investigator:||Frédéric de Blay, Pr.||Alyatec|
|Other Study ID Numbers:||
|First Posted:||October 12, 2020 Key Record Dates|
|Last Update Posted:||June 9, 2021|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Environmental Exposure Chamber
Allergen Exposure Chamber
Allergen provocation test
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases