Chronic Obstructive Pulmonary DiseaseCODENCT00890136
Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)
An observational study of Chronic Obstructive Pulmonary Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2014
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both Male and Female 40 years and older
Who may be able to join
- Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema
- Cigarette Smoking > 10 pack-years
- Age > 40 years
- Has not smoked > 1 year
- Post BD FEV1/FVC ≤ 70%
- Post BD FEV1 (% predicted) 30-80%
- Ability and willingness to provide consent
Who cannot join
- Non- English speaking
- Planning to move or live away from the home during the study period
- Co-morbid illnesses such as:
- Current physician diagnosis of Asthma
- Other pulmonary diseases
- Systemic disease requiring treatment with immunosuppressive agents
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- Known alpha-1 antitrypsin deficiency
- Occupational exposure with high endotoxin exposure
- Within the last 6 months Use of oral corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COpd and Domestic Endotoxin (CODE)
This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
statistical analysis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJul 2008
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Nadia Hansel, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890136
- Sponsor's protocol ID
- NA_00017777
- Acronym
- CODE
- Status last verified
- Jun 2019
- First submitted
- 27 Apr 2009
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COpd and Domestic Endotoxin (CODE)
- ClinicalTrials.gov ID
- NCT00890136
- Acronym / sponsor ID
- CODE / NA_00017777
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Jul 2008 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Apr 2009 (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.
This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both Male and Female 40 years and older
Key inclusion criteria (7 listed)
- Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema
- Cigarette Smoking > 10 pack-years
- Age > 40 years
- Has not smoked > 1 year
- Post BD FEV1/FVC ≤ 70%
Key exclusion criteria (9 listed)
- Non- English speaking
- Planning to move or live away from the home during the study period
- Co-morbid illnesses such as:
- Within the last 6 months Use of oral corticosteroids
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
statistical analysis
Time frame: one year
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 25 Jun 2019.
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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.
Nadia Hansel, MD, MPH principal investigator
Johns Hopkins University
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 Chronic Obstructive Pulmonary Disease, run by Johns Hopkins 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 7 inclusion and 9 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 25 Jun 2019. 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.
What does the primary outcome measure?
statistical analysis (time frame: one year). 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 25 Jun 2019.