Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ragweed-SPIRE 1 | Experimental | Ragweed-SPIRE regimen 1 given 2 weeks apart |
|
| Ragweed-SPIRE 2 | Experimental | Ragweed-SPIRE regimen 2 given 2 weeks apart |
|
| Placebo | Placebo Comparator | Placebo given 2 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ragweed-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 22 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 22 weeks | |
| Evaluation of change in lung function as a measure of safety and tolerability | Throughout subjects participation in the study, approximately 22 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanata Allergy Services | Kanata | Ontario | K2L 3C8 | Canada | ||
| Kingston General Hospital |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Biological |
|
| Kingston |
| Ontario |
| K7L 2V7 |
| Canada |
| Cheema Research Inc | Mississauga | Ontario | L5A 3V | Canada |
| Ottawa Allergy Research Corp | Ottawa | Ontario | K1Y 4G2 | Canada |
| Inflamax Research | Toronto | Ontario | L4W 1A4 | 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 |