Pulmonary Disease, Chronic ObstructiveNCT00756522
Analyzing Lung Tissue in People With and Without Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
An observational study of Pulmonary Disease, Chronic Obstructive, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD have difficulty breathing because of lung damage. However, for many people with COPD, while some areas of the lungs are damaged, other nearby areas are not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to May 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in this study will be adults with a clinically established need for lung transplantation and who are listed at Barnes-Jewish Hospital for lung transplantation because of COPD.
Who may be able to join
- Age equal to or greater than 18 years
- Ability to read and write in English
- Able to participate in the informed consent process
- Listed at Barnes-Jewish Hospital for lung transplantation for COPD (with alpha-1-antitrypsin deficiency [A1ATD] or non-1ATD)
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) class IV COPD
- Acceptable chest computed tomography (CT) exam completed at Barnes-Jewish Hospital in the 3 years before study entry
Who cannot join
- Pregnant
- Prisoner
- Vulnerable populations
- Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant
- Coexisting (other than COPD / emphysema / chronic bronchitis)significant pulmonary parenchymal disorder (e.g., pulmonary fibrosis)
- Inability to perform 10 to 15 second breath hold for 3-Helium MRI scan.
- Contraindications to MRI (including pacemaker, metal implants, other devices affected by the magnet).
- Contraindications to 3-Helium MRI (including significant anemia [hemoglobin less than or equal to 12 g/dL, with the last testing within 1 month of the MRI scan] or marked oxyhemoglobin desaturation at rest when breathing room air [requiring more than 4 liters per minute of supplemental oxygen to keep saturation of oxygen (SaO2) at least 90%]).However, patients deemed to be low risk kfor complications of cerebrovascular disease, cardiovascular disease, heart dysrhythmias, and seizures through the thorough lung transplant evaluation will be eligible for testing. Since most of the patients with these contraindications to 3-Helium MRI will be ineligible for lung transplantation, we expect few patients to have such contraindications to testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms for COPD. Detection: Lung Imaging and Profiling (Project 1)
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD have difficulty breathing because of lung damage. However, for many people with COPD, while some areas of the lungs are damaged, other nearby areas are not. This study will examine lung tissue from people with and without COPD who are undergoing lung transplantation to investigate how and why certain areas of the lungs are damaged in some people but not others.
Read the detailed description
COPD is a common lung disease and is the fourth most common cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath,and wheezing. There is no cure for COPD, and the disease worsens over time. Treatment can include stopping smoking, taking medications, receiving supplemental oxygen, and in severe cases, undergoing lung transplantation. COPD is usually the result of many years of cigarette smoking, but it remains unknown exactly how cigarette smoking causes this disease.
One reason that people with COPD experience shortness of breath and cough is because the lung airways are partly damaged and obstructed. In healthy people, oxygen is breathed in and then passes easily into the bloodstream through bunches of small air sacs that fill the lungs. In people with COPD, these air sacs are damaged, making it difficult for oxygen to pass into the bloodstream. However, even in people with severe COPD, the air sacs in some areas of the lungs continue to work, even though neighboring air sacs are damaged. It is possible that an overactive immune response may cause the air sac damage and that some people with COPD are more prone than others to such immune system abnormalities. By examining the differences in lung tissue in people with and without COPD who are undergoing a lung transplant, this study will investigate why some people's immune systems cause lung damage and others do not and how and why some air sacs are damaged while other nearby air sacs are not. Study researchers will also examine whether genetic factors play a role in the development and severity of COPD.
This study will enroll people with COPD who are undergoing lung transplantation. Before the lung transplantation surgery, participants will attend one study visit, which will include a medical history review, height and weight measurements, and a blood collection. A portion of blood will be stored for future genetic research. Participants will also complete questionnaires to collect information on activities, health, and quality of life. Some participants will undergo a 3-Helium magnetic resonance imaging (MRI) procedure, which is an imaging technique that allows doctors to see the air spaces inside of the lungs. After the lung transplantation surgery, study researchers will collect lung tissue from surgery. Study researchers will contact participants at the end of the study to collect follow-up medical information.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- There is no intervention. Study is observational.
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention. Study is observational.Other
There is no intervention. Study is observational.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Pierce, PhD, Principal investigator, Washington University School of Medicine, Pulmonary and Critical Care DivisionMichael Holtzman, MD, Study chair, Washington University School of Medicine, Pulmonary and Critical Care Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756522
- Sponsor's protocol ID
- 575-201109012
- Status last verified
- Jun 2018
- First submitted
- 19 Sep 2008
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms for COPD. Detection: Lung Imaging and Profiling (Project 1)
- ClinicalTrials.gov ID
- NCT00756522
- Acronym / sponsor ID
- 575-201109012
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Sep 2008 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is a long-term lung disease. People with COPD have difficulty breathing because of lung damage. However, for many people with COPD, while some areas of the lungs are damaged, other nearby areas are not. This study will examine lung tissue from people with and without COPD who are undergoing lung transplantation to investigate how and why certain areas of the lungs are damaged in some people but not others.
Detailed description
COPD is a common lung disease and is the fourth most common cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath,and wheezing. There is no cure for COPD, and the disease worsens over time. Treatment can include stopping smoking, taking medications, receiving supplemental oxygen, and in severe cases, undergoing lung transplantation. COPD is usually the result of many years of cigarette smoking, but it remains unknown exactly how cigarette smoking causes this disease.
One reason that people with COPD experience shortness of breath and cough is because the lung airways are partly damaged and obstructed. In healthy people, oxygen is breathed in and then passes easily into the bloodstream through bunches of small air sacs that fill the lungs. In people with COPD, these air sacs are damaged, making it difficult for oxygen to pass into the bloodstream. However, even in people with severe COPD, the air sacs in some areas of the lungs continue to work, even though neighboring air sacs are damaged. It is possible that an overactive immune response may cause the air sac damage and that some people with COPD are more prone than others to such immune system abnormalities. By examining the differences in lung tissue in people with and without COPD who are undergoing a lung transplant, this study will investigate why some people's immune systems cause lung damage and others do not and how and why some air sacs are damaged while other nearby air sacs are not. Study researchers will also examine whether genetic factors play a role in the development and severity of COPD.
This study will enroll people with COPD who are undergoing lung transplantation. Before the lung transplantation surgery, participants will attend one study visit, which will include a medical history review, height and weight measurements, and a blood collection. A portion of blood will be stored for future genetic research. Participants will also complete questionnaires to collect information on activities, health, and quality of life. Some participants will undergo a 3-Helium magnetic resonance imaging (MRI) procedure, which is an imaging technique that allows doctors to see the air spaces inside of the lungs. After the lung transplantation surgery, study researchers will collect lung tissue from surgery. Study researchers will contact participants at the end of the study to collect follow-up medical information.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be adults with a clinically established need for lung transplantation and who are listed at Barnes-Jewish Hospital for lung transplantation because of COPD.
Key inclusion criteria (6 listed)
- Age equal to or greater than 18 years
- Ability to read and write in English
- Able to participate in the informed consent process
- Listed at Barnes-Jewish Hospital for lung transplantation for COPD (with alpha-1-antitrypsin deficiency [A1ATD] or non-1ATD)
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) class IV COPD
Key exclusion criteria (8 listed)
- Pregnant
- Prisoner
- Vulnerable populations
- Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant
- Coexisting (other than COPD / emphysema / chronic bronchitis)significant pulmonary parenchymal disorder (e.g., pulmonary fibrosis)
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 |
|---|---|---|
| There is no intervention. Study is observational.There is no intervention. Study is observational. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
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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.
Richard Pierce, PhD principal investigator
Washington University School of Medicine, Pulmonary and Critical Care Division
Michael Holtzman, MD study chair
Washington University School of Medicine, Pulmonary and Critical Care Division
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 Pulmonary Disease, Chronic Obstructive, run by Washington University School of Medicine 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Jun 2018.