Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
NCT ID: NCT04663880
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2016-08-30
2017-02-15
Brief Summary
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The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne house dust mite allergen in Alyatec EEC.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Asthmatic subjects allergic to house dust mite
24 subjects were randomized in a doubleblinded manner into six subgroups. All were exposed first to placebo then in cross over to three different Der p1 concentrations, respectively 15, 25, and 46 ng/m3.
Exposure to placebo in EEC
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Exposure to three concentrations of HDM allergen in EEC
Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Asthmatic subjects not allergic to house dust mite
13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3.
Exposure to placebo in EEC
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Exposure to a single concentration of HDM allergen in EEC
Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Interventions
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Exposure to placebo in EEC
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Exposure to three concentrations of HDM allergen in EEC
Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Exposure to a single concentration of HDM allergen in EEC
Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Eligibility Criteria
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Inclusion Criteria
* Subjects affiliated to a social security scheme
* Positive metacholine test
* FEV1 value \> 70% of theoretical FEV1 value
* Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
Group A:
* Mild allergic asthma to HDM (GINA 1 or 2) with associated rhinitis and/or conjunctivitis.
* Positive skin prick-test to Dpt and Df (wheal diameter \>5 mm compared to the negative control)
* Specific immunoglobulin E (IgE) for Dpt and Df \> 0.7 kU/L
Group B:
* Mild allergic asthma (GINA 1 or 2) not sensitized to HDM with associated rhinitis and/or conjunctivitis.
* Negative skin prick-test and specific IgE for Dpt and Df.
* Positive skin prick-test and specific IgE for another allergen.
Exclusion Criteria
* Asthma Control Test (ACT) \< 20/25 in 4 weeks prior to EEC exposure
* Use of oral corticosteroids in the 4 weeks preceding inclusion in the study
* Use of biotherapy in the 4 months preceding inclusion in the study
* Existence of a severe obstructive syndrome with FEV1 \<70% of the theoretical value
* Obstruction triggered by spirometric evaluations
* Hospitalization for asthma or exacerbation in the last 4 weeks
* History of Acute Severe Asthma requiring hospitalization in intensive care or intubation
* Desensitization to dust mite allergens in the last 5 years
* Sensitization to allergens in the indoor environment (cat allergens or molds) with obvious exposure to these allergens
* Active tobacco: plus 10 cigarettes / day and tobacco history of +10 PA
* Uncontrolled systemic arterial hypertension
* Recent myocardial infarction (\<3 months)
* Recent stroke (\<3 months)
* Known arterial aneurysm
* Epilepsy under treatment
* Progressive tumor pathology
* Chronic renal pathology
* Hypersensitivity to one of the excipients used
* Subjects who participated in another clinical study in the three months prior to inclusion
18 Years
50 Years
ALL
No
Sponsors
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Alyatec
INDUSTRY
Responsible Party
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Principal Investigators
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Frédéric de Blay, Pr.
Role: PRINCIPAL_INVESTIGATOR
Alyatec
Locations
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Alyatec
Strasbourg, Grand Est, France
Countries
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References
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Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(R) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.
Related Links
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Alyatec website
Other Identifiers
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ALY-001
Identifier Type: -
Identifier Source: org_study_id