COPDNCT00571792
Evaluation of Airway Gene Expression in COPD and Controlled Populations
An observational study of COPD, run by University of Nebraska at 1 site in United States.
Trial summary
To explore potential proteins that may be used to develop novel therapies for COPD. This will be accomplished by acquiring material from the lower respiratory tract via endobronchial brushings. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2006to 1 Feb 2011
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males or non-pregnant, non-nursing females who are of non-childbearing potential between the ages of 45 and 70 years of age and who may be either life long non smokers, smokers who do not demonstrate symptoms of COPD and smokers who do demonstrate symptoms of COPD
Who may be able to join
- Age 45-70 yrs of age, incl, women as described above as far as child-bearing potential and subjects who if they have coexisting disease, the disease is stable and does not place an untoward risk or result in compromise of data.
- Non smokers will be lifelong and have not worked in a chronic dusty environment.
- Smokers will require a minimum of 10 pkyr history and currently smoking at least a pack per day. The smokers without symptoms of COPD must demonstrate a pulmonary function with an FEV1 > 80%. The FEV1/FVC ratio may be less than .7 however they can not demonstrate symptoms of chronic bronchitis by medical history. Smokers with symptoms must demonstrate an FEV1 < 80% and FEV1/FVC <.7.
Who cannot join
- Any female subject who is pregnant or breast-feeding or a female subject who is of child-bearing potential who is unwilling to sue two acceptable methods of birth control.
- Any condition that would place the subject at risk for endobronchial brushings(such as bleeding diathesis) or subjects who are currently taking anticoagulants.
- Any subject who has had an exacerbation of COPD within the last six months of screening or who has been hospitalized for any reason within the last three months.
- Illicit substances indicated by positive urine drug screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2465
About this study
To explore potential proteins that may be used to develop novel therapies for COPD. This will be accomplished by acquiring material from the lower respiratory tract via endobronchial brushings.
Read the detailed description
Chronic Obstructive Pulmonary Disease(COPD) is currently the fourth leading cause of death in the United States. COPD is characterized by reduced airflow that is largely irreversible and progressive. Smoking is recognized as the most important cause of COPD contributing up to 80% of the cases. The disease does demonstrate a significant variability in airflow obstruction during the progression of the disease among those who are diagnosed and treated. This is probably due not only to the role of exposure of cigarette smoke and other noxious inhaled particles and gases but also to the individual's varied responses to those exposures.
COPD is characterized by an inflammatory response that does have a number of components that may be present in variable amounts. Recent data suggests that the cigarette exposure may cause several distinct pathophysiological processes that in turn may account for the variability demonstrated in altered lung structure that leads to functional impairment. Current therapies can help with alleviation of symptoms in individuals but not the unaltered course of loss in lung function that frequently leads to respiratory failure and death.
New strategies have been discussed as a means to new therapeutic approaches to altering the course of the disease. The use of genomic and proteomic methodologies offer promise to identify the pathways critical and relevant to the progression of COPD. To date approved medications target only the inflammatory response to the disease.
The study will explore metabolic pathways that could affect the remodeling process associated with the disease. Because of the heterogeneity of COPD, characteristics of the individual as well as between individuals must be identified in more detail. Mechanisms that enable this not only include physiological characterization by the current prescribed interventions but also imaging data which provides such ability to quantify airway wall thickness as well as via DNA that will be collected and save in order to gain a better understanding between the methodologies as they relate to the characterization of COPD. Currently, there may be a common understanding of how a particular drug affects a detailed molecular mechanism, however frequently it is not known why. The purpose of this study is to assist in discovery of the why.
- Conditions
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| methodologies to identify characteristics of non-smokers with normal lung function | Imaging, genomic and proteomic methodologies to identify characteristics of individuals with normal lung function who do not smoke | |
| methodologies to identify characteristics of smokers but do not demonstrate symptoms of COPD | Imaging, genomic and proteomic methodologies to identify characteristics of individuals who smoke but who do not demonstrate symptoms of chronic obstructive pulmonary disease | |
| methodologies to identify characteristics of smokers that demonstrate symptoms of COPD | Imaging, genomic and proteomic methodologies to identify characteristics of individuals who smoke that demonstrate symptoms of COPD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study start1 Sep 2006
- Primary completion1 Feb 2011
- Study completion1 Feb 2011
Why it stopped: Insufficient enrollment
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 University of NebraskaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Stephen I Rennard, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571792
- Sponsor's protocol ID
- 0406-05-FB
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2007
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Airway Gene Expression in COPD and Controlled Populations
- ClinicalTrials.gov ID
- NCT00571792
- Acronym / sponsor ID
- 0406-05-FB
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- 1 Sep 2006 (actual)
- Primary completion
- 1 Feb 2011 (actual)
- Study completion
- 1 Feb 2011 (actual)
- First posted
- 12 Dec 2007 (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.
To explore potential proteins that may be used to develop novel therapies for COPD. This will be accomplished by acquiring material from the lower respiratory tract via endobronchial brushings.
Detailed description
Chronic Obstructive Pulmonary Disease(COPD) is currently the fourth leading cause of death in the United States. COPD is characterized by reduced airflow that is largely irreversible and progressive. Smoking is recognized as the most important cause of COPD contributing up to 80% of the cases. The disease does demonstrate a significant variability in airflow obstruction during the progression of the disease among those who are diagnosed and treated. This is probably due not only to the role of exposure of cigarette smoke and other noxious inhaled particles and gases but also to the individual's varied responses to those exposures.
COPD is characterized by an inflammatory response that does have a number of components that may be present in variable amounts. Recent data suggests that the cigarette exposure may cause several distinct pathophysiological processes that in turn may account for the variability demonstrated in altered lung structure that leads to functional impairment. Current therapies can help with alleviation of symptoms in individuals but not the unaltered course of loss in lung function that frequently leads to respiratory failure and death.
New strategies have been discussed as a means to new therapeutic approaches to altering the course of the disease. The use of genomic and proteomic methodologies offer promise to identify the pathways critical and relevant to the progression of COPD. To date approved medications target only the inflammatory response to the disease.
The study will explore metabolic pathways that could affect the remodeling process associated with the disease. Because of the heterogeneity of COPD, characteristics of the individual as well as between individuals must be identified in more detail. Mechanisms that enable this not only include physiological characterization by the current prescribed interventions but also imaging data which provides such ability to quantify airway wall thickness as well as via DNA that will be collected and save in order to gain a better understanding between the methodologies as they relate to the characterization of COPD. Currently, there may be a common understanding of how a particular drug affects a detailed molecular mechanism, however frequently it is not known why. The purpose of this study is to assist in discovery of the why.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methodologies to identify characteristics of non-smokers with normal lung function | – | –Imaging, genomic and proteomic methodologies to identify characteristics of individuals with normal lung function who do not smoke |
| methodologies to identify characteristics of smokers but do not demonstrate symptoms of COPD | – | –Imaging, genomic and proteomic methodologies to identify characteristics of individuals who smoke but who do not demonstrate symptoms of chronic obstructive pulmonary disease |
| methodologies to identify characteristics of smokers that demonstrate symptoms of COPD | – | –Imaging, genomic and proteomic methodologies to identify characteristics of individuals who smoke that demonstrate symptoms of COPD |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males or non-pregnant, non-nursing females who are of non-childbearing potential between the ages of 45 and 70 years of age and who may be either life long non smokers, smokers who do not demonstrate symptoms of COPD and smokers who do demonstrate symptoms of COPD
Key inclusion criteria (3 listed)
- Age 45-70 yrs of age, incl, women as described above as far as child-bearing potential and subjects who if they have coexisting disease, the disease is stable and does not place an untoward risk or result in compromise of data.
- Non smokers will be lifelong and have not worked in a chronic dusty environment.
- Smokers will require a minimum of 10 pkyr history and currently smoking at least a pack per day. The smokers without symptoms of COPD must demonstrate a pulmonary function with an FEV1 > 80%. The FEV1/FVC ratio may be less than .7 however they can not demonstrate symptoms of chronic bronchitis by medical history. Smokers with symptoms must demonstrate an FEV1 < 80% and FEV1/FVC <.7.
Key exclusion criteria (4 listed)
- Any female subject who is pregnant or breast-feeding or a female subject who is of child-bearing potential who is unwilling to sue two acceptable methods of birth control.
- Any condition that would place the subject at risk for endobronchial brushings(such as bleeding diathesis) or subjects who are currently taking anticoagulants.
- Any subject who has had an exacerbation of COPD within the last six months of screening or who has been hospitalized for any reason within the last three months.
- Illicit substances indicated by positive urine drug screen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Stephen I Rennard, MD principal investigator
University of Nebraska
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, run by University of Nebraska 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Dec 2023. 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 was stopped early (reason given: Insufficient enrollment). 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.
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 4 Dec 2023.