Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins

Completed

• Conditions: Therapeutic Proteins; Asthma

• Registration Number: NCT04514926
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-17
• Study Start: 2020-11-01
• Primary Completion: 2023-05-26
• Study Completion: 2023-05-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Lymphocyte	Up to 18 months	The investigators will compare lymphocyte counts in healthy controls to asthmatics on and off therapeutic proteins.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States