Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins (BLAST)
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|ClinicalTrials.gov Identifier: NCT04514926|
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : November 13, 2020
|Condition or disease|
|Asthma Therapeutic Proteins|
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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins|
|Actual Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||July 6, 2022|
|Estimated Study Completion Date :||July 6, 2022|
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.
- Number of Lymphocyte [ Time Frame: Up to 18 months ]The investigators will compare lymphocyte counts in healthy controls to asthmatics on and off therapeutic proteins.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514926
|Contact: Ariana Baum, BAfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Ariana Baum, BA 415-514-1539 email@example.com|
|Principal Investigator:||John V Fahy, MD||University of California, San Francisco|