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To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grass tablet 75,000 SQ-T | Experimental | Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phleum pratense grass pollen allergen extract | Drug | Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum | measurement of IgG4 in serum | baseline versus end of treatment (approx. 60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment | measurement of IgE in serum | baseline versus end of treatment (approx. 60 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dmitri Kazei, MD PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research facility ID ORG-001086 | Moscow | 105077 | Russia | |||
| Research facility ID ORG-001018 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Grass Tablet 75,000 SQ-T | Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | placebo tablet given once daily over 60 days |
|
| Moscow |
| 115446 |
| Russia |
| Research facility ID ORG-001005 | Moscow | 115478 | Russia |
| Research facility ID ORG-001009 | Moscow | 119333 | Russia |
| Research facility ID ORG-001016 | Moscow | 119991 | Russia |
| Research facility ID ORG-001006 | Moscow | 123182 | Russia |
| Research facility ID ORG-001085 | Moscow | 123182 | Russia |
| Research facility ID ORG-001014 | Moscow | 142190 | Russia |
| Research facility ID ORG-001007 | Saint Petersburg | 193231 | Russia |
| Research facility ID ORG-001019 | Saint Petersburg | 195030 | Russia |
| Research facility ID ORG-001008 | Saint Petersburg | 198216 | Russia |
| Research facility ID ORG-001015 | Samara | 443099 | Russia |
| Research facility ID ORG-001021 | Saratov | 410028 | Russia |
| Research facility ID ORG-001017 | Smolensk | 214019 | Russia |
| Research facility ID ORG-001020 | Ufa | 450000 | Russia |
Placebo
placebo: placebo tablet given once daily over 60 days
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Grass Tablet 75,000 SQ-T | Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days |
| BG001 | Placebo | Placebo placebo: placebo tablet given once daily over 60 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum | measurement of IgG4 in serum | In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data. | Posted | Mean | Standard Deviation | mgA/L | baseline versus end of treatment (approx. 60 days) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment | measurement of IgE in serum | In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data. | Posted | Mean | Standard Deviation | UA/ml | baseline versus end of treatment (approx. 60 days) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Grass Tablet 75,000 SQ-T | Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days | 0 | 53 | 26 | 53 | ||
| EG001 | Placebo | Placebo placebo: placebo tablet given once daily over 60 days | 0 | 54 | 12 | 54 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oral pruritus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tongue oedema | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Respiratory tract infection viral | Infections and infestations | Non-systematic Assessment |
| ||
| Ear pruritus | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dmitri Kazei MD, PhD | Abbott | +31 294477008 | dmitri.kazei@abbott.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C551013 | Grazax |
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| >=65 years |
|
| Male |
|
|