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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthmatic subjects allergic to house dust mite | Experimental | 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. |
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| Asthmatic subjects not allergic to house dust mite | Active Comparator | 13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to placebo in EEC | Other | Patients are exposed to placebo (saline solution) in the EEC for 4h maximum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The bronchial response is evaluated by measuring FEV1 value during EEC exposure. Early asthmatic response (EAR) occurs when a 20% drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15% drop in FEV1 or 20% drop in peak flow is detected 1 to 6h after the EAR. | 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of allergenic exposure in EEC | Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC | 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure |
| Evaluate the metrology of the EEC |
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Inclusion Criteria:
Group A:
Group B:
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30919704 | Result | 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. |
| Label | URL |
|---|---|
| Alyatec website | View source |
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Randomized, double blind, cross-over study including two study groups
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| Exposure to three concentrations of HDM allergen in EEC | Other | Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum |
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| Exposure to a single concentration of HDM allergen in EEC | Other | Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum |
|
The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.
| 4 hours of exposure in EEC |
| Evaluate the specificity of the bronchial response | The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM. | 4 hours of exposure in EEC |
| Evaluate the effect of the exposure on rhinitis symptoms | The effect of the exposure on the rhinitis response is assessed with Total Nasal Symptom Score (TNSS). The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity). | 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure |
| Evaluate the effect of the exposure on conjunctivitis symptoms | The effect of the exposure on the conjunctivitis response is assessed with Total Ocular Symptom Score (TOSS). The TOSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity). | 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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