Asthma
Conditions
Brief summary
We are using anti-IgE to investigate the role of pulmonary mast cells in asthma.
Detailed description
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.
Interventions
DRUGXolair
Patients are administered Xolair
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Mild asthma, adults -
Exclusion criteria
children. on inhaled or systemic steroids \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment from the University community
Pre-assignment details
No events prior to the study
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Xolair |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xolair | 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 | 18 Units of anti-KLH antibody | Standard Error 2 |
Comparison: This is not a drug study.p-value: <0.01t-test, 2 sided