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This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, 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 cat allergen in Alyatec EEC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthmatic subjects allergic to cat | Experimental | Group A will be randomized into 2 subgroups of 10 subjects: group A1 and A2. Both subgroupes will be exposed to placebo on exposure 1 then Subgroup A1 will be exposed to dose A on exposure 2 and dose B on exposure 3. Subgroup A2 will be exposed to dose B on exposure 2 and dose A on exposure 3. Dose A and B correspond to different Allergen concentration in the EEC. |
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| Asthmatic allergic subjects not sensitized to cat | Active Comparator | Group B will be exposed to placebo at exposure 1, and then at exposure 2, the concentration of cat allergens corresponding to the dose that achieved the main objective (Dose A or B). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to Placebo | Other | Patients are exposed to placebo in the EEC |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat. | The bronchial response is evaluated by measuring FEV1 value. Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR. | 10 hours: 4 hours of exposure in EEC then 6 hours post-exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of allergenic exposure in EEC | Safety is assessed with an asthma symptom self-report questionnaire performed during the 4h exposure and for 24h after the end of the exposure. The score was obtained from the sum of all four individual symptom scores (chest tightness, cough, wheezing and dyspnea) with a total possible score ranging from 0 (no symptoms) to 16 (maximum symptom intensity). |
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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 |
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| Label | URL |
|---|---|
| Alyatec website | View source |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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Randomized, double blind, cross-over study including two study groups
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| Exposure to dose A and dose B of cat allergen | Other | Patients are exposed to dose A and B for successive exposures in the EEC |
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| Exposure to a single dose of cat allergen | Other | Patients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B) |
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| 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure |
| Evaluate the allergen concentration in the EEC | The measurement of allergen concentration is performed with several sensors positioned in the chamber. | 4 hours exposure in EEC |
| Evaluate the specificity of the bronchial response | The specificity of the bronchial response is assessed with the exposure to cat allergen in the EEC of asthmatic allergic subjects non sensitized to cat. | 4 hours 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |