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Decision made to stop study following availability of results from another study
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The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grass-SPIRE | Experimental | Eight intradermal injections of Grass-SPIRE |
|
| Placebo | Placebo Comparator | Eight intradermal injections of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass-SPIRE | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Score of symptoms and allergy medication | Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication | Approximately 66 weeks |
| Safety of Grass-SPIRE | Measurement of adverse events | Approximately 66 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Scores | Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects | Approximately 66 weeks |
| Rescue Medication Use | Use of allergy medication to help allergy symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Bernstein, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canton | Ohio | United States | ||||
| Bernstein Clinical Research Center, LLC |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D003231 | Conjunctivitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| Approximately 66 weeks |
| Quality of Life | Assessment of Quality of Life measured by responses to a questionnaire | Approximately 66 weeks |
| Cincinnati |
| Ohio |
| 45231 |
| United States |
| D010038 |
| Otorhinolaryngologic Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |