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| Name | Class |
|---|---|
| Medicom | UNKNOWN |
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There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.
All patients should have positive skin prick tests and specific IgE to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne Bet v 1 in ALYATEC environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen.
Allergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with face mask | Experimental | Birch pollen allergen exposure in ALYATEC chamber with face mask |
|
| Patients without face mask | No Intervention | Birch pollen allergen exposure in ALYATEC chamber without face mask |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOLMI® surgical face mask (OP-Air) | Device | 12 subjects are exposed to birch pollen allergen in ALYATEC EEC while wearing a KOLMI® surgical face mask (OP-Air) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to early asthma response (EAR) | The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC | 0 to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of EAR and late asthma response (LAR) | The efficacy of face mask is evaluaed by the frequency of EAR and LAR during and after birch pollen allergen exposure in EEC | 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR) |
| Severity of EAR and LAR |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric de Blay, Pr | Chest Diseases Department, Strasbourg University Hospital, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALYATEC | Strasbourg | France |
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| Label | URL |
|---|---|
| Study results | View source |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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The efficacy of face mask is evaluated by the maximum percentage of drop of FEV1during and after EEC exposure |
| 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR) |
| Nasal Symptoms | The efficacy of face mask is evaluated with specific questionnaire (Total Nasal Symptoms Score - TNSS) | 0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score) |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |