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The primary objective of this study is to demonstrate that SLIT administered pre-and co-seasonally is effective in reducing rhinoconjunctivitis symptoms during the entire short ragweed pollen season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Ragweed Pollen Allergenic Extract | Experimental |
| |
| Glycero-COCAs | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Ragweed Pollen Allergenic Extract | Biological | Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season. |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores] | Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable. | 2011 ragweed pollen season, 8/2011 -10/2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season) | Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 7 | Warrenton | Virginia | 20186 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Ragweed Pollen Allergenic Extract | Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season. Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual |
| FG001 | Glycero-COCAs | Placebo-Glycero-COCAs sublingual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ragweed Allergenic Extract | Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season. Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual |
| BG001 | Glycero-COCAs |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores] | Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable. | ITT population includes subjects who had at least one post treatment efficacy measurement | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 2011 ragweed pollen season, 8/2011 -10/2011 |
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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 | Ragweed Allergenic Extract | allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season. placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terrance Coyne, M.D., Executive Vice President of Research & Development; Chief Medical Officer | GREER Laboratories, Inc. | (828) 759-7495 | tcoynemd@greerlabs.com |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Placebo | Biological | Placebo: Glycero-COCAs sublingual |
|
| 3 peak weeks of the 2011 ragweed pollen season |
| Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season) | Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season. | 2011 ragweed pollen season; 8/2011 - 10/2011 |
| Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season) | Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS). Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season. | 3 peak weeks of the 2011 ragweed pollen season |
Placebo: Glycero-COCAS sublingual |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Ragweed Allergenic Extract | Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season. Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual |
| OG001 | Placebo (Glycero-Cocas) | Placebo: Glycero-COCAs sublingual |
|
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| Secondary | Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season) | Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable. | ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 3 peak weeks of the 2011 ragweed pollen season |
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| Secondary | Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season) | Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season. | ITT population includes subjects who had at least one post treatment efficacy measurement | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 2011 ragweed pollen season; 8/2011 - 10/2011 |
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| Secondary | Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season) | Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS). Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season. | ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 3 peak weeks of the 2011 ragweed pollen season |
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| 2 |
| 218 |
| 28 |
| 218 |
| EG001 | Glycero-Cocas | placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual | 3 | 211 | 29 | 211 |
| Nausea | Gastrointestinal disorders |
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| Dehydration | Metabolism and nutrition disorders |
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| Vomiting | Gastrointestinal disorders |
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| Nephrolithiasis | Renal and urinary disorders |
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| Cardiac failure congestive | Cardiac disorders |
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| Surgery | Surgical and medical procedures |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
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| Headache | Nervous system disorders |
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