Chronic Obstructive Lung DiseaseNCT00814203
A Registry of COPD Patients to be Used for Future Studies
An observational study of Chronic Obstructive Lung Disease, run by Philip Diaz at 1 site in United States.
Trial summary
To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2010
- 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: primary care clinic
Who may be able to join
- Patients who are 18 years of age and older who have been diagnosed with COPD by at least one of the following:
- clinical history-a documented history of COPD, emphysema, or chronic bronchitis;
- pulmonary function results (defined as an FEV1/FVC less than 0.7;
- radiographic results (high-resolution CT findings of emphysema
Who cannot join
- in ability to give informed consent
- prisoners
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ohio State University COPD Registry
To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies.
Read the detailed description
To develop a cohort of COPD participants for study staff to determine the most likely candidates for future studies and to develop a repository of blood from subjects with COPD for future studies.
- Conditions
- Chronic Obstructive Lung Disease
- 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 |
|---|---|---|
| Chronic obstructive lung disease | those with a condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a registry protocol to determine factors contributing to the development of chronic obstructive lung disease.
Secondary outcomes (1)
To develop a repository of blood from subjects with COPD for future studies. These studies may include evaluation of biologic markers of disease severity and progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Diaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philip Diaz, Ohio State University
- Investigators
- Philip Diaz, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814203
- Sponsor's protocol ID
- 2007H0248
- Status last verified
- Oct 2021
- First submitted
- 23 Dec 2008
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ohio State University COPD Registry
- ClinicalTrials.gov ID
- NCT00814203
- Acronym / sponsor ID
- 2007H0248
- Conditions
- Chronic Obstructive Lung Disease
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Philip DiazUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Dec 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.
To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies.
Detailed description
To develop a cohort of COPD participants for study staff to determine the most likely candidates for future studies and to develop a repository of blood from subjects with COPD for future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive lung disease | – | –those with a condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- Patients who are 18 years of age and older who have been diagnosed with COPD by at least one of the following:
Key exclusion criteria (3 listed)
- in ability to give informed consent
- prisoners
- pregnancy
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
This is a registry protocol to determine factors contributing to the development of chronic obstructive lung disease.
1 secondary outcome
To develop a repository of blood from subjects with COPD for future studies. These studies may include evaluation of biologic markers of disease severity and progression.
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 29 Oct 2021.
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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.
Philip Diaz, MD principal investigator
Ohio State 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 Lung Disease, run by Philip Diaz 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 4 inclusion and 3 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 29 Oct 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?
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?
This is a registry protocol to determine factors contributing to the development of chronic obstructive lung disease.. 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 29 Oct 2021.