Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins

Conditions
-----------------
Asthma, Therapeutic Proteins

Participation Criteria
=================
Eligibility Criteria
-----------------
Group 1: Inclusion Criteria: Male or female between the ages of 18 and 80 years at Visit 1 and at least 50% whose age is >40 years (to ensure age balance among groups and anticipating that groups 1 and 2 will be older). Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Able to perform reproducible spirometry according to ATS criteria. Exclusion Criteria: History of asthma or other lung disease. History of allergic rhinitis. URI within the previous 6 weeks. Smoking of tobacco or other recreational inhalants in last month and/or >10 pack-year smoking history. Currently pregnant. Abnormal spirometry. Group 2 Inclusion Criteria Male or female between the ages of 18 and 80 years at Visit 1 Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Able to perform reproducible spirometry according to ATS criteria. Asthma requiring treatment with therapeutic proteins but not yet started on treatment. Exclusion Criteria Asthma exacerbation or URI (upper respiratory infection) within the previous 6 weeks. Smoking of tobacco or other recreational inhalants in last month and/or >10 pack-year smoking history. Currently pregnant. Other chronic pulmonary disorders, including cystic fibrosis and chronic obstructive pulmonary disease. Use of other therapeutic proteins in the past 6 months. Group 3 Inclusion Criteria: Male or female between the ages of 18 and 80 years at Visit 1 Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Able to perform reproducible spirometry according to ATS criteria. Asthma already being treated with therapeutic proteins for at least 6 months. Exclusion Criteria Asthma exacerbation or URI within the previous 6 weeks. Smoking of tobacco or other recreational inhalants in last month and/or >10 pack-year smoking history. Currently pregnant. Other chronic pulmonary disorders, including cystic fibrosis and chronic obstructive pulmonary disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Controls<br>Participants with no history of asthma or other lung diseases. | |
| Asthmatics newly prescribed therapeutic proteins<br>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<br>Participants with asthma who have already started on therapeutic proteins. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, therapeutics, therapeutic proteins