Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins (BLAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514926
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : February 1, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Asthma Therapeutic Proteins

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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
Blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Xavier Orain, BS 415-502-3472 xavier.orain@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Ariana Baum, BA    415-514-1539    ariana.baum@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: John V Fahy, MD University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04514926    
Other Study ID Numbers: 20-30026
2P01HL107202-06A1 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
asthma
therapeutics
therapeutic proteins
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases