Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins (BLAST)

February 9, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthmatic patients seen in the outpatient chest faculty practice (clinic) at UCSF Parnassus campus.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

July 6, 2024

Study Completion (ANTICIPATED)

July 6, 2024

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-30026
  • 2P01HL107202-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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