COPDVAPORNCT04880551
Ventilation Imbalances in Mild to Moderate Chronic Obstructive Pulmonary Disease
An observational study of COPD and Dyspnea, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- COPD, Dyspnea, Respiratory Disease
- What is being tested?
- Fluoroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to 25 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Adult, Older adult
Study population: We plan to enroll patients presenting to OHSU hospital or clinics with clinical diagnoses of COPD and a recent spirometry.
Who may be able to join
- Age 30 - 85 years at Visit 1 and willing to give informed consent to participate, signed or electronic.
- A female is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
- Childbearing potential has a negative serum pregnancy test at Visit 1, and agrees to an acceptable method of contraception considered appropriate by patient's primary care provider.
- COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) [Celli, 2004]: Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
- Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)].
Show all 10Show fewer
- COPD Severity: Subjects with an established clinical history of COPD and severity defined as: FEV1/FVC ratio must be <0.70 and FEV1 between 40-80% of predicted normal value calculated using NHANES III reference equations.
- Clinical data reviewed by the investigator does not suggest any harm to the patient from study enrollment.
- Chest x-ray or computed tomography (CT) scan of the chest/lungs if available do not have clinically significant abnormalities not believed to be due to the presence of COPD
- Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments.
Who cannot join
- Women who are pregnant or lactating or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Respiratory:
- Asthma: Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Alpha-1 Antitrypsin Deficiency: Subjects who have alpha-1 antitrypsin deficiency as the cause of COPD.
- Other Respiratory Disorders: Subjects who have other active pulmonary disease such as active tuberculosis, lung cancer, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea (i.e., in the opinion of the Investigator severity of the disorder would impact the conduct of the study). Note: Allergic rhinitis is not exclusionary.
- Lung Volume Reduction: Subjects who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants) within 6 months of Visit 1.
Show all 19Show fewer
- Hospitalization or acute COPD worsening: Subjects who have been hospitalized due to poorly controlled COPD within 2 weeks prior to Visit 1 (Screening)
- Chest x-ray (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment or put the subject at risk because of participation in the study.
- Spirometry Performance:
- Acceptability: Subjects who cannot perform acceptable spirometry (i.e., meet ATS/ERS acceptability criteria)
- Repeatability: Subjects who cannot perform technically acceptable spirometry with at least 3 acceptable flow-volume curves with 2 or more meeting ATS repeatability criteria for FEV1 during at least 1 of the pre-bronchodilator assessments
- Subjects who are medically unable to withhold their short-acting bronchodilators for the six hour period prior to spirometry testing.
- Oxygen / non-invasive positive pressure ventilation device: Subjects receiving long-term-oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 15 hours a day or using non-invasive positive pressure ventilation device. Note: Subjects using continuous positive airway pressure or bi-level positive airway pressure for Sleep Apnea Syndrome are allowed in the study if not used for ventilatory support.
- Cardiac disease:
- Subjects who have unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 6 months of enrollment.
- Subjects with a recent history of acute coronary syndrome, or who have undergone percutaneous coronary intervention or coronary artery bypass graft within the past 3 months are to be excluded.
- Subjects with congestive heart failure (CHF NYHA Class III/IV).
- Clinically significant abnormal ECG with conduction abnormality or arrhythmia considered significant by principal investigator.
- Investigational drugs or devices: treatment with investigational study drug or device in another clinical study within four weeks of study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health Science University
Portland, Oregon, 97239
About this study
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.
Read the 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:
- Conditions
- COPD, Dyspnea, Respiratory Disease, Lung Diseases
- Being tested
- Fluoroscopy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Respiration Disorders, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoroscopyRadiation
Also called 4DXV Lung Ventilation Analysis Software (LVAS)
In this study the patient will be exposed to radiation during the fluoroscopy for lungs. There is a small chance of alopecia. There is a rare chance that the patients skin may turn red or be damaged.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with a recent Spirometry | Patients that have a diagnosis of COPD and have completed a recent Pulmonary Function Test - Spirometry. Receives: Radiation: Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of imaging data
Determine the XV Lung Ventilation Analysis Software quantification of ventilation defect percentage and ventilation heterogeneity in COPD.
Data will be quantified by the number of participants yielding significant ventilation defect percentages and ventilation heterogeneity in patients with COPD. Data acquired will be used to assess COPD severity using the COPD Severity Score.
Measured: 18 months
Clinical Assessment of Lung Function
Determine if XV Lung Ventilation Analysis Software provides enhanced clinical assessment of lung function as compared to standard spirometry, 6MWT, SGRQ and recent-CT.
Measured: 18 Months
Clinical assessment and correlation with imaging
Determine if the ventilation defect percentage and ventilation heterogeneity are associated with the change in COPD assessment test after onset of therapy. Measurements of ventilation defect percentage and ventilation heterogeneity will be compared to changes in COPD assessments during the study.
COPD Assessments Test will be used to assess changes from Baseline measurements and 12 week assessment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start30 Jun 2021 (estimated)
- Primary completion25 Apr 2023 (estimated)
- Study completion25 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- 4DMedical
- Responsible party
- Principal investigator, Akram Khan, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880551
- Sponsor's protocol ID
- IRB00022285
- Acronym
- VAPOR
- Status last verified
- Jun 2021
- First submitted
- 12 Apr 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation Imbalances in Mild to Moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04880551
- Acronym / sponsor ID
- VAPOR / IRB00022285
- Conditions
- COPD, Dyspnea, Respiratory Disease, Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- 4DMedical
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 25 Apr 2023 (estimated)
- Study completion
- 25 Apr 2024 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients with a recent Spirometry | – | Radiation: FluoroscopyPatients that have a diagnosis of COPD and have completed a recent Pulmonary Function Test - Spirometry. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We plan to enroll patients presenting to OHSU hospital or clinics with clinical diagnoses of COPD and a recent spirometry.
Key inclusion criteria (10 listed)
- Age 30 - 85 years at Visit 1 and willing to give informed consent to participate, signed or electronic.
- A female is eligible to enter and participate in the study if she is of:
- COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) [Celli, 2004]: Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
- Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)].
- COPD Severity: Subjects with an established clinical history of COPD and severity defined as: FEV1/FVC ratio must be <0.70 and FEV1 between 40-80% of predicted normal value calculated using NHANES III reference equations.
Key exclusion criteria (19 listed)
- Women who are pregnant or lactating or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Respiratory:
- Spirometry Performance:
- Oxygen / non-invasive positive pressure ventilation device: Subjects receiving long-term-oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 15 hours a day or using non-invasive positive pressure ventilation device. Note: Subjects using continuous positive airway pressure or bi-level positive airway pressure for Sleep Apnea Syndrome are allowed in the study if not used for ventilatory support.
- Cardiac disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoroscopyAlso: 4DXV Lung Ventilation Analysis Software (LVAS)In this study the patient will be exposed to radiation during the fluoroscopy for lungs. There is a small chance of alopecia. There is a rare chance that the patients skin may turn red or be damaged. | Radiation | COPD patients with a recent Spirometry |
Primary outcome
Quantification of imaging data
Time frame: 18 months
Determine the XV Lung Ventilation Analysis Software quantification of ventilation defect percentage and ventilation heterogeneity in COPD. Data will be quantified by the number of participants yielding significant ventilation defect percentages and ventilation heterogeneity in patients with COPD. Data acquired will be used to assess COPD severity using the COPD Severity Score.
Clinical Assessment of Lung Function
Time frame: 18 Months
Determine if XV Lung Ventilation Analysis Software provides enhanced clinical assessment of lung function as compared to standard spirometry, 6MWT, SGRQ and recent-CT.
Clinical assessment and correlation with imaging
Time frame: 18 months
Determine if the ventilation defect percentage and ventilation heterogeneity are associated with the change in COPD assessment test after onset of therapy. Measurements of ventilation defect percentage and ventilation heterogeneity will be compared to changes in COPD assessments during the study. COPD Assessments Test will be used to assess changes from Baseline measurements and 12 week assessment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- OHSU Pulmonary Critical Care MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Dyspnea, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of imaging data (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.