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| ID | Type | Description | Link |
|---|---|---|---|
| 2P01HL107202-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is an observational, clinic-based, single center study of 120 subjects. Participants will be comprised of patients seen in the outpatient faculty practice in ambulatory care at the UCSF Parnassus campus. Study investigators will enroll 20 healthy participants with no history of lung disease, 50 asthmatics who are newly prescribed therapeutic proteins for their asthma, and 50 asthmatics already being treated with therapeutic proteins for their asthma. Participants will be seen at 1 to 3 visits and provide blood samples at each visit.
Asthma is a common disease affecting 5 - 10% of the population. The main underlying pathology is airway inflammation, which in a majority of patients is characterized by upregulation of type 2 cytokines and infiltration of the airway mucosa with type 2 inflammatory cells. Despite incomplete understanding of mechanisms by which these molecules and cells initiate and propagate the inflammatory process, several new therapies have been developed and even approved to target type 2 cytokines like IL-4, IL-5 and IL13 in asthmatics.
While mechanistic understanding lags behind therapeutic advance, the emergence of these new therapeutics and increase use in treatment of asthmatic patients provides a unique opportunity to better understand how these medicines alter inflammation and ameliorate disease activity. The over-arching goal of this project is to advance understanding of how these new therapeutic proteins modulate inflammation in peripheral blood. A better understanding of these mechanisms will allow for tracking of cellular and molecular biomarkers that may inform treatment regimens with these new therapeutics in patients with asthma.
Through this observational, clinic-based, single center study of 120 subjects, investigators will compare blood lymphocytes as well as other molecular biomarkers associated with inflammation in healthy controls, asthmatic patients not on therapeutic proteins and asthmatics treated with therapeutic proteins. Participants will be comprised of patients seen in the outpatient faculty practice in ambulatory care at the UCSF Parnassus campus. Participants will be seen at 1 to 3 visits and provide blood samples at each visit. It is anticipated that this study will help uncover mechanisms of response to these novel therapeutic interventions in asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Participants with no history of asthma or other lung diseases. | ||
| Asthmatics newly prescribed therapeutic proteins | Participants with asthma, have been newly prescribed therapeutic proteins and have yet to start on those therapeutics at the time of enrollment. | ||
| Asthmatics already being treated with therapeutic proteins | Participants with asthma who have already started on therapeutic proteins. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Lymphocyte | The investigators will compare lymphocyte counts in healthy controls to asthmatics on and off therapeutic proteins. | Up to 18 months |
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Group 1:
Inclusion Criteria:
Exclusion Criteria:
Group 2
Inclusion Criteria
Exclusion Criteria
Group 3
Inclusion Criteria:
Exclusion Criteria
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Asthmatic patients seen in the outpatient chest faculty practice (clinic) at UCSF Parnassus campus.
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| Name | Affiliation | Role |
|---|---|---|
| John V Fahy, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| Label | URL |
|---|---|
| Airway Clinical Research Center website | View source |
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There is no plan to make IPD available to other researchers.
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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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Blood
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |