Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722835
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2020-12-09
Brief Title:
Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease COPD-Susceptible Smokers
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Lung Macrophage Populations and Functions in Chronic Obstructive Pulmonary Disease COPD-Susceptible Smokers
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pre-COPD Pilot
Brief Summary:
Chronic Obstructive Pulmonary Disease COPD is a heterogeneous disease that affects only a fraction of those who smoke tobacco The origin of this variability in susceptibility to develop COPD is unclear but understanding its underlying biology has important implications for our ability to design suitable preventative and therapeutic strategies for its management This Department of Defense DOD discovery research proposes to develop methodologies and generate preliminary data needed to lay the foundation for a large study that would investigate the underlying biological susceptibility of those who smoke tobacco to develop COPD
Detailed Description:
This is a pilot observational study of 20 subjects 40 years of age with smoking history of at least 20 pack-years former or current who have preserved spirometry as defined by normal Forced Expiratory Volume FEV1 Forced Vital Capacity FVC Of the 20 subjects 10 with and 10 without air trapping as determined by high and abnormal versus low and normal Residual Volume RV Total Lung Capacity TLC measured by plethysmography The cohort will undergo extensive clinical characterization including full Pulmonary Function Testing PFT and medical symptom activity and quality of life questionnaires assessment including modified Medical Council Research mMRC COPD Assessment Test CAT Short Form-12 SF12 and St Georges Respiratory SGRQ questionnaires Subjects will undergo bronchoscopy with bronchoalveolar lavage BAL to obtain luminal macrophages and BAL fluid BALF Live BAL cells BALF and BAL cell RNA will be collected and stored in our biorepository for proposed studies Molecular functional and transcriptomics analyses of luminal alveolar macrophages obtained by BAL Aim 2 and protease activity measurement in serum and BALF will be performed Aim 2 and will be examined against the clinical phenotype of the subjects in particular air trapping-phenotype to see if an underlying biological signature for susceptibility to develop COPD could be identified
To perform a more comprehensive molecular and functional phenotype examination of lung macrophages additional methodologies will be developed including a second mass cytometry CyTOF panel for single-cell proteomics and CyTOF-based phagocytosis and efferocytosis assays to allow for performance of truly single-cell functional phenotyping of myeloid cells from BAL and lung tissue Aim 1
To perform a more comprehensive molecular and functional phenotype examination of lung macrophages additional methodologies will be developed including a second mass cytometry CyTOF panel for single-cell proteomics and CyTOF-based phagocytosis and efferocytosis assays to allow for performance of truly single-cell functional phenotyping of myeloid cells from BAL and lung tissue Aim 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None