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The aim of this study is to determine the optimal concentration of grass pollen allergens inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen exposure chamber.
Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0, 30, 60 and 90 ng/m3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Concentration A - Concentration B - Concentration C - Concentration D |
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| Group 2 | Other | Concentration B - Concentration C - Concentration D - Concentration A |
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| Group 3 | Other | Concentration C - Concentration D - Concentration A - Concentration B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass Pollen Allergen Exposure | Other | After the screening visit, subjects are randomized into 3 groups presenting a sequence of allergen concentrations with randomly defined concentrations of Ph l p 5 (0, 30, 60 and 90 ng/m3). Each participant undergo four different 3-hour exposure sessions to grass pollen allergen corresponding to the four different allergen concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhino-conjunctivitis response in subjects allergic to grass pollen during 3 hours of exposure to grass pollen allergens in the ALYATEC Environmental Exposure Chamber (EEC) | The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhino-conjunctivitis TSS (Total Symptoms Score). The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms) | 0 to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to obtain a rhino-conjunctivitis response during the 3 hours of exposure to grass pollen allergens in the ALYATEC EEC | The exposure time will be determined by the time necessary to obtain the first uncorrected TSS (Total Symptoms Score) score ≥ 12 and corrected ≥ 10. The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms) | 0 to 3 hours |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALYATEC | Strasbourg | France |
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| Label | URL |
|---|---|
| ALYATEC website | View source |
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Single-center, randomized, crossover, double-blind, controlled study.
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The grass pollen allergen (Phl p 5) concentrations corresponding to concentrations A, B, C and D are assigned randomly by the technician and the pharmacist of the exposure chamber so that neither the investigator, the participants nor the clinical and medical staff are aware of the exposure doses.
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| Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhinitis response in subjects allergic to grass pollen during 3 hours of exposure to grass allergens in the ALYATEC Environmental Exposure Chamber (EEC) | The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhinitis-related questions of the TSS (nasal congestion, rhinorrhea, nasal itching, sneezing). The value of the rhinitis-related questions of the TSS varies from 0 (no symptom) to 12 (highest symptoms) | 0 to 3 hours |
| Frequency of bronchial response during 3 hours of exposure in the ALYATEC EEC | The frequency of bronchial response will be assessed by determining the number of subjects presenting at least one drop of FEV1 ≥ 20% during the 3 hours of exposure in ALYATEC EEC. | 0 to 3 hours |
| Use of concomitant medications during and after exposures in the EEC ALYATEC | The use of concomitant medications will be assessed by determining the number of subjects using at least one treatment during and up to 24 hours after the exposure. | 0 to 24 hours |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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