Clinical trial NCT04663880: Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
Official title: Validation Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Allergy to House Dust
Allergy
Keywords: Allergy
Asthma
House dust mite
Lead sponsor: Alyatec
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double blind, cross-over study including two study groups
Primary purpose: OTHER

Brief summary: This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

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.


Eligibility criteria: Inclusion Criteria:

* Subjects having signed the informed consent
* 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:

* Uncontrolled asthma
* 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

Primary outcomes:
measure: Determine the concentration of HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM
timeFrame: 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
Secondary outcomes:
measure: Evaluate the safety of allergenic exposure in EEC
timeFrame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
measure: Evaluate the metrology of the EEC
timeFrame: 4 hours of exposure in EEC
measure: Evaluate the specificity of the bronchial response
timeFrame: 4 hours of exposure in EEC
measure: Evaluate the effect of the exposure on rhinitis symptoms
timeFrame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
measure: Evaluate the effect of the exposure on conjunctivitis symptoms
timeFrame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Alyatec
state: Grand Est
Study officials:
affiliation: Alyatec
name: Frédéric de Blay, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.