Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04880551
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventilation Imbalances in Mild to Moderate Chronic Obstructive Pulmonary Disease
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Ventilation Imbalances in Mild to Moderate Chronic Obstructive Pulmonary Disease
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
ENROLLING_BY_INVITATION
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:
VAPOR
Brief Summary:
The Investigators plan a single center study to get preliminary data to answer a number of fundamental questions directly related to management of COPD. The research will determine whether ventilation heterogeneity and distribution of ventilation inform, determine, assist or drive the: 1) status or clinical course in patients with COPD, 2) understanding of factors associated with activities of daily living and quality of life in patients , 3) risk of exacerbation or hospitalization in those with COPD, and 4) predictors of therapeutic pathway or treatment regime.
Detailed Description:
The Investigators plan a single center study to get preliminary data to answer a number of fundamental questions directly related to management of COPD. The research will determine whether ventilation heterogeneity and distribution of ventilation inform, determine, assist or drive the: 1) status or clinical course in patients with COPD, 2) understanding of factors associated with activities of daily living and quality of life in patients , 3) risk of exacerbation or hospitalization in those with COPD, and 4) predictors of therapeutic pathway or treatment regime.
Specific Aims
Aim 1: Determine if XV Lung Ventilation Analysis Software yields valid and clinically useful quantification of ventilation in COPD subjects.
The goal of aim 1 is to develop the practical and technical components to deploy XF functional lung imaging within the institution in collaboration with, pulmonary and radiology, infrastructure from information technology and administration. After initial testing, LVAS will be deployed in the institution for the study and validated against data from 4DMedical.
Aim 2: Determine if XV Lung Ventilation Analysis Software provides enhanced clinical assessment of lung function as compared to standard spirometry, SGRQ, COPD assessment test (CAT), Borg dyspnea score, mMRC questionnaire, 6MWT, and recent-CT.
In aim 2, the Investigators will take patients presenting to our outpatient clinics or recently discharged from the hospital with presence of COPD in spirometry and approach them for consenting for the study. After informed consent Investigators will collect baseline demographic data, study questionnaires and assess functional capacity using 6MWT and perform a noncontrast CT chest if not performed previously and perform fluoroscopy to get data for 4DXV lung imaging. Patients will continue with their usual pharmacological therapies and exercise program. These data points will be repeated between 4-8 weeks and 10-14 weeks to get very short-term (4-8 weeks) and short-term (10-14 weeks) changes in clinical assessment, spirometry and 4DXV lung imaging.
Aim 3: Determine the sample size for effect for future studies in COPD patients.
In aim 3, investigators will analyze data generated in aim 2 to determine if there are very short and short-term changes in spatial distribution of lung ventilation with changes in patient's clinical condition as determined by clinical assessment and spirometry to determine if the 4DXV technology can be used to study and understand progression of COPD in patients with mild to moderate disease. Data generated with the used to analyze the sample size necessary to perform a multicenter study incorporating the use of 4DXV technology in the management of patients with mild-moderate COPD and to determine what data points from the 4DXV technology can be used in clinical trials of COPD.
Each aim of the proposal will generate several products for clinical and research audiences to better understand and develop the use of 4DXV technology. The Investigators plan to develop two products using this results of the study:
Specific Aims
Aim 1: Determine if XV Lung Ventilation Analysis Software yields valid and clinically useful quantification of ventilation in COPD subjects.
The goal of aim 1 is to develop the practical and technical components to deploy XF functional lung imaging within the institution in collaboration with, pulmonary and radiology, infrastructure from information technology and administration. After initial testing, LVAS will be deployed in the institution for the study and validated against data from 4DMedical.
Aim 2: Determine if XV Lung Ventilation Analysis Software provides enhanced clinical assessment of lung function as compared to standard spirometry, SGRQ, COPD assessment test (CAT), Borg dyspnea score, mMRC questionnaire, 6MWT, and recent-CT.
In aim 2, the Investigators will take patients presenting to our outpatient clinics or recently discharged from the hospital with presence of COPD in spirometry and approach them for consenting for the study. After informed consent Investigators will collect baseline demographic data, study questionnaires and assess functional capacity using 6MWT and perform a noncontrast CT chest if not performed previously and perform fluoroscopy to get data for 4DXV lung imaging. Patients will continue with their usual pharmacological therapies and exercise program. These data points will be repeated between 4-8 weeks and 10-14 weeks to get very short-term (4-8 weeks) and short-term (10-14 weeks) changes in clinical assessment, spirometry and 4DXV lung imaging.
Aim 3: Determine the sample size for effect for future studies in COPD patients.
In aim 3, investigators will analyze data generated in aim 2 to determine if there are very short and short-term changes in spatial distribution of lung ventilation with changes in patient's clinical condition as determined by clinical assessment and spirometry to determine if the 4DXV technology can be used to study and understand progression of COPD in patients with mild to moderate disease. Data generated with the used to analyze the sample size necessary to perform a multicenter study incorporating the use of 4DXV technology in the management of patients with mild-moderate COPD and to determine what data points from the 4DXV technology can be used in clinical trials of COPD.
Each aim of the proposal will generate several products for clinical and research audiences to better understand and develop the use of 4DXV technology. The Investigators plan to develop two products using this results of the study:
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: