Clinical trial NCT04514926: Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins
Official title: Blood Lymphocytes in Asthmatics Treated With Therapeutic Proteins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Therapeutic Proteins
Keywords: asthma
therapeutics
therapeutic proteins
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatic patients seen in the outpatient chest faculty practice (clinic) at UCSF Parnassus campus.

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.

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.

Primary outcomes:
measure: Number of Lymphocyte
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: John V Fahy, MD
role: PRINCIPAL_INVESTIGATOR
References: