Ventilation Imbalances in Mild to Moderate Chronic Obstructive Pulmonary Disease

NCT04880551 | Unknown DMC FDA Device

• 1 other identifier: IRB00022285
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Dyspnea; Respiratory Disease; Lung Diseases

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  18 months

Study Arms (1)

COPD patients with a recent Spirometry

Patients that have a diagnosis of COPD and have completed a recent Pulmonary Function Test - Spirometry.

Radiation: Fluoroscopy

Interventions

Fluoroscopy RADIATION

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.

Also known as: 4DXV Lung Ventilation Analysis Software (LVAS)

COPD patients with a recent Spirometry

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to enroll patients presenting to OHSU hospital or clinics with clinical diagnoses of COPD and a recent spirometry.

You may qualify if:

• 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. \[Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)\].
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• 4DMedical: collaborator

Study Sites (1)

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Related Links

• OHSU Pulmonary Critical Care Medicine

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Respiration Disorders; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 10, 2021
• Study Start: June 30, 2021
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2024
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)