- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397861
T Cell Memory Fuels the Innate Response in Chronic CF Lung Disease
September 28, 2022 updated by: National Jewish Health
This study seeks to define the role of CD4+ and CD8+ T cell memory responses in the immunologic failure of patients with cystic fibrosis (CF) to clear infections.
In a normal host, the immune system clears pathogens upon re-infection more swiftly and efficiently than during an initial infection, in great part due to the recall and effector functions of memory T cells.
In CF, far less is understood regarding the response of T cell memory when hosts reencounter antigens, otherwise known as pulmonary exacerbations.
Pulmonary exacerbations are pivotal events that lead to a decline in health status among CF patients, with many never recovering to baseline health.
CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health.
Following enrollment at the time of antibiotic initiation, blood will be collected at two different time points.
The first samples will be collected within 24 hours of starting IV antibiotic therapy.
The second blood specimen will be collected at the end of hospitalization, after a minimum of 5 days.
At the time of each blood draw, complete blood counts, a sputum sample, and simple spirometry will be measured as part of the standard care of a CF exacerbation.
Isolated PBMCs will be stained with antibodies to designate cell surface phenotype.
They will then be sorted to identify the T cell population.
These cells will be tested on their ability to clear pathogens.
The relationship between cellular immune responses and clinical indicators of pulmonary status will be examined by fitting linear mixed models.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
112
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
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Colorado
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Denver, Colorado, United States, 80206
- National Jewish Health
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult CF subjects will be recruited from patients followed by the Adult CF Program at National Jewish Health at the onset of an acute pulmonary exacerbation.
Description
Inclusion Criteria:
- Documented diagnosis of CF.
- Age 18 years old or greater.
- Hospitalization with planned IV antibiotic treatment for a pulmonary exacerbation of CF.
- Ability to perform reproducible Pulmonary Function Tests and produce sputum.
- Willingness to comply with study procedure and willingness to provide written consent.
Exclusion Criteria:
- Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
- Use of systemic steroids at the start of IV treatment for a pulmonary exacerbation
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate CD4+ and CD8+ T cell function during CF pulmonary exacerbation
Time Frame: average 10 days
|
Prospectively evaluate CD4+ and CD8+ T cell function as measured from the peripheral blood in patients with cystic fibrosis (CF) and its correlation with improvements in pulmonary inflammation and clinical status during treatment of CF pulmonary exacerbations.
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average 10 days
|
Evaluate CD4+ and CD8+ T cell function during CF pulmonary exacerbation
Time Frame: a period of 60 months
|
Prospectively evaluate CD4+ and CD8+ T cell function as measured from the peripheral blood in patients with cystic fibrosis (CF) and its correlation with improvements in pulmonary inflammation and clinical status during treatment of CF pulmonary exacerbations.
|
a period of 60 months
|
Test the capacity of enhanced CFTR activity to bolster host inflammatory cell function
Time Frame: average 10 days
|
Compare CF effector memory responses between those clinically prescribed a CFTR modulator and those not currently on treatment as measured by flow cytometry.
The ability of CF effector T cells to control infection over time will change over the subject's lifetime and use of CFTR modulators.
|
average 10 days
|
Test the capacity of enhanced CFTR activity to bolster host inflammatory cell function
Time Frame: a period of 60 months
|
Compare CF effector memory responses between those clinically prescribed a CFTR modulator and those not currently on treatment as measured by flow cytometry.
The ability of CF effector T cells to control infection over time will change over the subject's lifetime and use of CFTR modulators.
|
a period of 60 months
|
Test the capacity of T cell subsets to control infection over time
Time Frame: average 10 days
|
Compare CF effector memory responses between those who are infected frequently (2 or more times/year) and those infected infrequently (0-1 times/year) as measured by flow cytometry.
The ability of CF effector T cells to control infection over time will change over the subject's lifetime and number of exacerbations.
|
average 10 days
|
Test the capacity of T cell subsets to control infection over time
Time Frame: a period of 60 months
|
Compare CF effector memory responses between those who are infected frequently (2 or more times/year) and those infected infrequently (0-1 times/year) as measured by flow cytometry.
The ability of CF effector T cells to control infection over time will change over the subject's lifetime and number of exacerbations.
|
a period of 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
May 6, 2015
Primary Completion (Actual)
May 1, 2019
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
May 18, 2020
First Submitted That Met QC Criteria
May 20, 2020
First Posted (Actual)
May 21, 2020
Study Record Updates
Last Update Posted (Actual)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAAVED16GO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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