Status:
COMPLETED
Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Therapeutic Proteins
Eligibility:
All Genders
18-80 years
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...
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 cytokin...
Eligibility Criteria
Inclusion
- Group 1:
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04514926
Start Date
November 1 2020
End Date
May 26 2023
Last Update
July 30 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143