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| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
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The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to subjects suffering from both grass allergy and asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grass-SPIRE 1 | Experimental | Grass-SPIRE regimen 1 given 2 weeks apart |
|
| Grass-SPIRE 2 | Experimental | Grass-SPIRE regimen 2 given 2 weeks apart |
|
| Placebo | Placebo Comparator | Placebo given 2 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass-SPIRE | Biological | Intradermal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | Throughout subjects participation in the study, approximately 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with asthma exacerbations as a measure of safety and tolerability | Throughout subjects participation in the study, approximately 15 weeks | |
| Evaluation of change in lung function as a measure of safety and tolerability | Throughout subjects participation in the study, approximately 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada | ||
| Cheema Research Inc |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Placebo |
| Biological |
Intradermal injection |
|
| Mississauga |
| Ontario |
| L5A 3V |
| Canada |
| Inflamax Research | Mississauga | Ontario | L8P 0A1 | Canada |
| Ottawa Allergy Research Corp | Ottawa | Ontario | K1Y 4G2 | Canada |
| Centre de Recherche Appliquée en Allergie de Québec | Québec | Quebec | Canada |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |