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| ID | Type | Description | Link |
|---|---|---|---|
| Cetero Research - P2CR09001 | |||
| Health Canada - 9427-A1556-24C |
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| Name | Class |
|---|---|
| Cetero Research, San Antonio | NETWORK |
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The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Solution resembling the active solutions, but without allergen extract |
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| Cat hair allergen extract, dose group 1 | Experimental |
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| Cat hair allergen extract, dose group 2 | Experimental |
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| Cat hair allergen extract, dose group 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific allergen immunotherapy (placebo) | Biological | Drops for sublingual administration, 0 mcg (placebo), once daily administration for 16 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | During 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rhinoconjunctivitis symptom score | After 0, 8, and 16 weeks of treatment | |
| Overall rhinoconjunctivitis symptom score | After 0, 8, and 16 weeks of treatment | |
| Acoustic Rhinometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepen Patel, MD, CCFP | Cetero Research, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Mississauga | Ontario | L4W 1N2 | Canada |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Specific allergen immunotherapy | Biological | Drops for sublingual administration, 4.5 mcg Fel d1/day, once daily administration for 16 weeks. |
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| Specific allergen immunotherapy | Biological | Drops for sublingual administration, 9.0 mcg Fel d1/day, once daily administration for 16 weeks |
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| Specific allergen immunotherapy | Biological | Drops for sublingual administration, 18.0 mcg Fel d1/day, once daily administration for 16 weeks |
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| After 0, 8, and 16 weeks of treatment |
| Environmental Exposure Chamber Quality of Life | After 0, 8, and 16 weeks of treatment |
| Serum immunology | After 0, 8, and 16 weeks of treatment |
| Nasal secretion immunology | After 0 and 16 weeks of treatment |
| Safety lab testing (clinical chemistry, haematology, urinalysis) | After 0 and 16 weeks of treatment |