Chronic Obstructive Pulmonary DiseaseNCT00889447
Screening Evaluation for Studies of Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to study mechanisms of progression of COPD and to develop treatments for it. The investigators are doing the present study to identify people age 40 and older with mild to moderate COPD who will qualify for such studies to include in a database. 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
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 2017
- 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
- Age 40 years and older, either sex
- Mild to moderate COPD (FEV1/Forced vital capacity (FVC) ratio ≤ 0.70, FEV1 30-70% predicted, Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥35% predicted)
- On stable maintenance therapy for 2 months
- Current or former smoker (patient report of at least a 10 pack-year history)
- Ability to understand and willingness to sign consent documents
Who cannot join
- COPD exacerbation requiring treatment within past 6 weeks
- Untreated arterial hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg)
- Decompensated heart failure
- Myocardial infarction within past 3 months or ever
- Evidence of interstitial, occupational or chronic infectious lung disease
- Renal dysfunction
- Supplemental oxygen > 2 liters/m at rest
- Failure to keep screening appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224
About this study
Official title: Screening Evaluation for Studies of COPD
This research is being done to study mechanisms of progression of COPD and to develop treatments for it. The investigators are doing the present study to identify people age 40 and older with mild to moderate COPD who will qualify for such studies to include in a database. The study will include establishing a screening evaluation or characterization of the following two studies:
- Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980
- Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA_00001771
Read the detailed description
This is a program to recruit and screen participants for clinical trials or more detailed observational studies of COPD. There are no interventions or comparative results to be published from this study.
- 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.
Establish a screening evaluation or characterization
We are doing the present study to identify people to include in a database who are age 40 and older with mild to moderate COPD and who will qualify for studies of COPD. The study will include establishing a screening evaluation or characterization for the following three studies.
- Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980
- Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA_00001771
- Genetic Epidemiology of Chronic Obstructive Pulmonary Disease - NA_00011524
Measured: Determined during screening clinical visit
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 startJan 2008
- Primary completionMay 2017
- Study completionMay 2017
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
- Cross-sectional
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gregory Diette, MD,MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889447
- Sponsor's protocol ID
- NA_00013323
- Other IDs
- 1P50HL084945
- Status last verified
- Mar 2018
- First submitted
- 27 Apr 2009
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Evaluation for Studies of COPD
- ClinicalTrials.gov ID
- NCT00889447
- Acronym / sponsor ID
- NA_00013323
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary disease (COPD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2008 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (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 research is being done to study mechanisms of progression of COPD and to develop treatments for it. The investigators are doing the present study to identify people age 40 and older with mild to moderate COPD who will qualify for such studies to include in a database. The study will include establishing a screening evaluation or characterization of the following two studies:
- Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980
- Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA_00001771
Detailed description
This is a program to recruit and screen participants for clinical trials or more detailed observational studies of COPD. There are no interventions or comparative results to be published from this study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
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 (5 listed)
- Age 40 years and older, either sex
- Mild to moderate COPD (FEV1/Forced vital capacity (FVC) ratio ≤ 0.70, FEV1 30-70% predicted, Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥35% predicted)
- On stable maintenance therapy for 2 months
- Current or former smoker (patient report of at least a 10 pack-year history)
- Ability to understand and willingness to sign consent documents
Key exclusion criteria (8 listed)
- COPD exacerbation requiring treatment within past 6 weeks
- Untreated arterial hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg)
- Decompensated heart failure
- Myocardial infarction within past 3 months or ever
- Evidence of interstitial, occupational or chronic infectious lung disease
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
Establish a screening evaluation or characterization
Time frame: Determined during screening clinical visit
We are doing the present study to identify people to include in a database who are age 40 and older with mild to moderate COPD and who will qualify for studies of COPD. The study will include establishing a screening evaluation or characterization for the following three studies. * Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980 * Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA_00001771 * Genetic Epidemiology of Chronic Obstructive Pulmonary Disease - NA_00011524
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 12 Mar 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.
Gregory Diette, MD,MHS 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 5 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 12 Mar 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.
What does the primary outcome measure?
Establish a screening evaluation or characterization (time frame: Determined during screening clinical visit). 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 12 Mar 2018.