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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is designed to determine if treatment with abatacept is effective in decreasing allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen challenge (SAC) will be performed. The subjects will be randomized to either placebo or abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary endpoint will be to determine if treatment with abatacept results in a 50% or greater decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid following SAC as compared to placebo control. Secondary endpoints include measures of airway obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of the safety of abatacept administration in this subject population.
please see summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Abatacept | Experimental | Administration of Abatacept intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. |
|
| Placebo | Placebo Comparator | Administration of placebo (normal saline) intravenously 10 mg/kg every 2 weeks for 3 doses, followed by every 4 weeks for 2 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept | Drug | Treatment with abatacept, 10 mg/kg IV, for 5 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge | collected prior to randomization to abatacept or placebo | baseline |
| Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept | 3 months |
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Inclusion Criteria:
Subjects must meet all of the following criteria:
Exclusion Criteria:
Patients must have none of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Green, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23292882 | Result | Parulekar AD, Boomer JS, Patterson BM, Yin-Declue H, Deppong CM, Wilson BS, Jarjour NN, Castro M, Green JM. A randomized controlled trial to evaluate inhibition of T-cell costimulation in allergen-induced airway inflammation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):494-501. doi: 10.1164/rccm.201207-1205OC. Epub 2013 Jan 4. |
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recruited from asthma patient subject registry
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo : Treatment with Placebo, IV |
| FG001 | Treatment With Abatacept | abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo : Treatment with Placebo, IV |
| BG001 | Treatment With Abatacept | abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses. |
| 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 |
| 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 | Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge | collected prior to randomization to abatacept or placebo | Posted | Mean | Standard Deviation | percentage of cells | baseline |
|
|
6 months
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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 | Placebo | Placebo : Treatment with Placebo, IV |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jonathan Green | Washington University | 314-747-3591 | jgreen@wustl.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Placebo | Drug | Treatment with Placebo, IV |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept | Posted | Mean | Standard Deviation | percentage of cells | 3 months |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Treatment With Abatacept | abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses. | 0 | 13 | 0 | 13 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |