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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).
Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:
Objectives:
Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy.
Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT
Hypotheses:
Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics.
Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well.
Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all patients received Xolair/active drug | Experimental | One arm:active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANTI-IGE THERAPY (XOLAIR) | Drug | Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change in Sputum Markers by End of Study | sputum markers were classified as eosinophilic or non eosinophilic | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control | 32 weeks | |
| Number Participants for Whom Sputum Induction Was Safe | safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARIPAZ B MORALES, MD | CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eosinophilic Phenotype | participants received Xolair per standard clinical practice |
| FG001 | Non Eosinophilic Phenotype | participants received Xolair per standard clinical practice |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| every 4 weeks up to 32 weeks |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eosinophilic Phenotype | participants received Xolair per standard clinical practice |
| BG001 | Non Eosinophilic Phenotype | participants received Xolair per standard clinical practice |
| 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 |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| number of participants with eosinophilic or non eosinophilic (neutrophilic) sputum | The category of eosinophilic patients were based on their sputum eosinophils of >2.5% of total cells. The non eosinophilic patients on the other hand have >50% of neutrophils and <2.5 % eosinophils in their total sputum cells. | Count of Participants | Participants |
| |||||||||||||||||
| asthma severity | Count of Participants | 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 | Number of Participants With Change in Sputum Markers by End of Study | sputum markers were classified as eosinophilic or non eosinophilic | Posted | Count of Participants | Participants | 32 weeks |
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| Secondary | Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control | Posted | Count of Participants | Participants | 32 weeks |
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| Secondary | Number Participants for Whom Sputum Induction Was Safe | safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved | Posted | Count of Participants | Participants | every 4 weeks up to 32 weeks |
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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 | Eosinophilic Phenotype | participants received xolair per standard practice | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | Non Eosinophilic Phenotype | participants received xolair per standard practice | 0 | 6 | 0 | 6 | 0 | 6 |
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Difficulty enrolling patients and therefore had a small study population, limiting the results of the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MARIPAZ MORALES MD | CHILDREN'S HOSPITAL OF THE KING'S DAUGHTERS | 7576688255 | MARIPAZ.MORALES@CHKD.ORG |
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| neutrophilic sputum |
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| moderate |
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