| ID | Type | Description | Link |
|---|---|---|---|
| R01HL044253 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.
Subjects with mild allergic asthma are examined before, immediately after and 2 months after a course of treatment with anti-IgE. The following are examined: Allergen skin tests, allergen induced asthma, peripheral blood basophils, pulmonary bronchial mucosal mast cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| xolair | Experimental | This is a single arm, parallel study examining differences of therapeutic outcomes of Xolair. Xolair is being examined as an intervention that might change the outcome of immunization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xolair | Drug | Patients are administered Xolair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution | Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. This is measured by ELISA and expressed as ELISA units which are derived by dilution of serum samples until the result falls on a linear portion of the response curve. Final values are derived from ELISA units and the serum dilution | 6 months |
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Inclusion Criteria:
Mild asthma, adults -
Exclusion Criteria:
children. on inhaled or systemic steroids
-
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| Name | Affiliation | Role |
|---|---|---|
| Mark Schuyler, MD | UNM HSC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM HSC | Albuquerque | New Mexico | 87131 | United States |
No events prior to the study
Recruitment from the University community
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| ID | Title | Description |
|---|---|---|
| FG000 | Xolair | This is not a drug study examining differences of therapeutic outcomes. This is an open label, non randomized single dose level study in which patients will be treated for 85 days with rhuMAB-E25 (Xolair) and followed for a total of 300 days. The dose of Xolair is determined by the patient's total serum IgE and body weight and is administered subcutaneously every 2 or 4 weeks. Outcome is serum anti-KLH antibody (immunoglobulin classes). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xolair | This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization. |
| 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 | Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of the Response Curve. Final Values Are Derived From ELISA Units and the Serum Dilution | Asthma and control patients are immunized with KLH. Mean levels of anti-KLH antibody as described above. This is measured by ELISA and expressed as ELISA units which are derived by dilution of serum samples until the result falls on a linear portion of the response curve. Final values are derived from ELISA units and the serum dilution | Anti-KLH antibody levels of the groups (asthmatics treated with Xolair and placebo) were compared. Both parametric and non parametric statistical techniques were used. There were no differences between the groups. | Posted | Mean | Standard Error | Units of anti-KLH antibody | 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 | Xolair | This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Schuyler | University of New Mexico Health Sciences Center | 5059254197 | mschuyler@salud.unm.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This is not a drug study examining differences of therapeutic outcomes. It uses Xolair as an intervention that might change the outcome of immunization.
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |