Chronic Obstructive Pulmonary Disease (COPD)NCT01880177
Developing a COPD Case Finding Methodology for Primary Care
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University of Michigan at 4 sites in United States.
Trial summary
The purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk COPD cases in primary care and support content validity of the measure. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 346 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2013to Jan 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited through multiple clinic settings, i.e., pulmonology clinics, internal medicine clinics, and primary care/family medicine clinics.
Who may be able to join
- 1. Age ≥40 years
- 2. Current smokers (>10 pk yrs.) or Ex-smokers with a history of >10 pk yrs. or Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life
- 3. Stable state PFT values from within the last 12 months available or obtainable
- 4. Willing and able to attend the focus group session or cognitive interview
- 5. Able to read and speak in English
- 6. Willing and able to provide written Informed Consent
Who cannot join
- 1. Cognitive impairment, hearing or sight difficulty, or severe psychopathology that could interfere with ability to participate in the study
- 2. Patient was hospitalized for respiratory infection within the past 30 days
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Kentucky
Lexington, Kentucky, 40536
Columbia University Medical center / New York Presbyterian Hospital
New York, New York, 10032
UNMC College of Medicine
Omaha, Nebraska, 68198
About this study
Official title: A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases
The purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk COPD cases in primary care and support content validity of the measure. This work will build on the results of a comprehensive literature review and data mining analyses by identifying the symptomatic and health event experiences of at-risk and newly diagnosed patients, as described by the patients themselves. Specific objectives are as follows:
Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The qualitative information obtained in these focus groups will be used to develop a new questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.
Read more
Objective 2: To review the new questionnaire with a new set of participants with a recent COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b) the content of each question is appropriate and understandable to participants, (c) the intended connotation of each questions is consistent with participants' interpretation or assigned meaning, and (d) to assure that content is not seen as redundant across items. This will be done through one-on-one cognitive interviews.
Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without or with a new diagnosis of COPD and the consistency of readings between electronic and mechanical readings in these patients. This information will be used to inform the development of peak-flow meter instructions for use as part of the screening methodology.
- 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 |
|---|---|---|
| Current smokers | Current smokers (>10 pk yrs.) | |
| Ex-smokers | Ex-smokers with a history of >10 pk yrs | |
| Never-smokers | Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Case Finding Tool
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- United BioSource, LLC, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Fernando J. Martinez, MD, MS, University of Michigan
- Investigators
- Fernando J Martinez, MD, MS, Principal investigator, University of MichiganNancy K Leidy, PhD, Principal investigator, United BioSource, LLCDavid Mannino, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880177
- Sponsor's protocol ID
- HUM00068783
- Other IDs
- 7R01HL114055-03
- Status last verified
- May 2016
- First submitted
- 10 Jun 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. Chronic obstructive pulmonary disease surveillance--United States, 1971-2000. Respir Care. 2002 Oct;47(10):1184-99.
PubMed 12354338Centers for Disease Control and Prevention (CDC). Deaths from chronic obstructive pulmonary disease--United States, 2000-2005. MMWR Morb Mortal Wkly Rep. 2008 Nov 14;57(45):1229-32.
PubMed 19008792Brown DW, Croft JB, Greenlund KJ, Giles WH. Trends in hospitalization with chronic obstructive pulmonary disease-United States, 1990-2005. COPD. 2010 Feb;7(1):59-62. doi: 10.3109/15412550903499548.
PubMed 20214464Mannino DM, Gagnon RC, Petty TL, Lydick E. Obstructive lung disease and low lung function in adults in the United States: data from the National Health and Nutrition Examination Survey, 1988-1994. Arch Intern Med. 2000 Jun 12;160(11):1683-9. doi: 10.1001/archinte.160.11.1683.
PubMed 10847262Anzueto A, Sethi S, Martinez FJ. Exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2007 Oct 1;4(7):554-64. doi: 10.1513/pats.200701-003FM.
PubMed 17878469Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.
PubMed 20843247Roche N, Gaillat J, Garre M, Meunier JP, Lemaire N, Bendjenana H. Acute respiratory illness as a trigger for detecting chronic bronchitis in adults at risk of COPD: a primary care survey. Prim Care Respir J. 2010 Dec;19(4):371-7. doi: 10.4104/pcrj.2010.00042.
PubMed 20842324Langsetmo L, Platt RW, Ernst P, Bourbeau J. Underreporting exacerbation of chronic obstructive pulmonary disease in a longitudinal cohort. Am J Respir Crit Care Med. 2008 Feb 15;177(4):396-401. doi: 10.1164/rccm.200708-1290OC. Epub 2007 Nov 29.
PubMed 18048806Gruffydd-Jones K, Loveridge C. The 2010 NICE COPD Guidelines: how do they compare with the GOLD guidelines? Prim Care Respir J. 2011 Jun;20(2):199-204. doi: 10.4104/pcrj.2011.00011.
PubMed 21437566Wilt TJ, Niewoehner D, MacDonald R, Kane RL. Management of stable chronic obstructive pulmonary disease: a systematic review for a clinical practice guideline. Ann Intern Med. 2007 Nov 6;147(9):639-53. doi: 10.7326/0003-4819-147-9-200711060-00009.
PubMed 17975187Postma D, Anzueto A, Calverley P, Jenkins C, Make BJ, Sciurba FC, Similowski T, van der Molen T, Eriksson G. A new perspective on optimal care for patients with COPD. Prim Care Respir J. 2011 Jun;20(2):205-9. doi: 10.4104/pcrj.2011.00041.
PubMed 21559550Albert RK, Connett J, Bailey WC, Casaburi R, Cooper JAD, Criner GJ, Curtis JL, Dransfield MT, Han M, Lazarus SC, Make B, Marchetti N, Martinez FJ, Madinger NE, McEvoy C, Niewoehner DE, Porsasz J, Price CS, Reilly J, Scanlon PD, Sciurba FC, Scharf SM, Washko GR, Woodruff PG, and Anthonisen NR for the COPD Clinical Research Network. Chronic Administration of Azithromycin Decreases the Frequency of Chronic Obstructive Pulmonary Disease Exacerbations. Results of a Randomized Trail. NEJM 2011. In Press.
Wilt TJ, Niewoehner D, Kim C, Kane RL, Linabery A, Tacklind J, Macdonald R, Rutks I. Use of spirometry for case finding, diagnosis, and management of chronic obstructive pulmonary disease (COPD). Evid Rep Technol Assess (Summ). 2005 Aug;(121):1-7. doi: 10.1037/e439492005-001. No abstract available.
PubMed 16238364Van Schayck CP, Loozen JM, Wagena E, Akkermans RP, Wesseling GJ. Detecting patients at a high risk of developing chronic obstructive pulmonary disease in general practice: cross sectional case finding study. BMJ. 2002 Jun 8;324(7350):1370. doi: 10.1136/bmj.324.7350.1370.
PubMed 12052807Freeman D, Nordyke RJ, Isonaka S, Nonikov DV, Maroni JM, Price D, Halbert RJ. Questions for COPD diagnostic screening in a primary care setting. Respir Med. 2005 Oct;99(10):1311-8. doi: 10.1016/j.rmed.2005.02.037. Epub 2005 Apr 18.
PubMed 16140231
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases
- ClinicalTrials.gov ID
- NCT01880177
- Acronym / sponsor ID
- HUM00068783
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- United BioSource, LLC, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Jun 2013 (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.
The purpose of this qualitative work is to inform the content and structure of a new screening measure for identifying undiagnosed at-risk COPD cases in primary care and support content validity of the measure. This work will build on the results of a comprehensive literature review and data mining analyses by identifying the symptomatic and health event experiences of at-risk and newly diagnosed patients, as described by the patients themselves. Specific objectives are as follows:
Objective 1: To elicit concepts and symptom descriptions of COPD from patients with a recent diagnosis of COPD and those without a diagnosis but with risk factors for the disease. The qualitative information obtained in these focus groups will be used to develop a new questionnaire for identifying undiagnosed at-risk COPD cases in various clinic settings.
Objective 2: To review the new questionnaire with a new set of participants with a recent COPD diagnosis or those at risk for COPD to ensure that: (a) the instructions are clear, (b) the content of each question is appropriate and understandable to participants, (c) the intended connotation of each questions is consistent with participants' interpretation or assigned meaning, and (d) to assure that content is not seen as redundant across items. This will be done through one-on-one cognitive interviews.
Objective 3: To gather data on the ease/difficulty of peak flow meter use by people without or with a new diagnosis of COPD and the consistency of readings between electronic and mechanical readings in these patients. This information will be used to inform the development of peak-flow meter instructions for use as part of the screening methodology.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current smokers | – | –Current smokers (>10 pk yrs.) |
| Ex-smokers | – | –Ex-smokers with a history of >10 pk yrs |
| Never-smokers | – | –Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through multiple clinic settings, i.e., pulmonology clinics, internal medicine clinics, and primary care/family medicine clinics.
Key inclusion criteria (6 listed)
- 1. Age ≥40 years
- 2. Current smokers (>10 pk yrs.) or Ex-smokers with a history of >10 pk yrs. or Never-smokers, defined as ≤100 cigarettes/pipes/cigars over life
- 3. Stable state PFT values from within the last 12 months available or obtainable
- 4. Willing and able to attend the focus group session or cognitive interview
- 5. Able to read and speak in English
Key exclusion criteria (2 listed)
- 1. Cognitive impairment, hearing or sight difficulty, or severe psychopathology that could interfere with ability to participate in the study
- 2. Patient was hospitalized for respiratory infection within the past 30 days
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
COPD Case Finding Tool
Time frame: 24 months
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 11 May 2016.
- Background: PubMed 12354338Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. Chronic obstructive pulmonary disease surveillance--United States, 1971-2000. Respir Care. 2002 Oct;47(10):1184-99.
- Background: PubMed 19008792Centers for Disease Control and Prevention (CDC). Deaths from chronic obstructive pulmonary disease--United States, 2000-2005. MMWR Morb Mortal Wkly Rep. 2008 Nov 14;57(45):1229-32.
- Background: PubMed 20214464Brown DW, Croft JB, Greenlund KJ, Giles WH. Trends in hospitalization with chronic obstructive pulmonary disease-United States, 1990-2005. COPD. 2010 Feb;7(1):59-62. doi: 10.3109/15412550903499548.
- Background: PubMed 10847262Mannino DM, Gagnon RC, Petty TL, Lydick E. Obstructive lung disease and low lung function in adults in the United States: data from the National Health and Nutrition Examination Survey, 1988-1994. Arch Intern Med. 2000 Jun 12;160(11):1683-9. doi: 10.1001/archinte.160.11.1683.
- Background: PubMed 17878469Anzueto A, Sethi S, Martinez FJ. Exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2007 Oct 1;4(7):554-64. doi: 10.1513/pats.200701-003FM.
- Background: PubMed 20843247Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.
- Background: PubMed 20842324Roche N, Gaillat J, Garre M, Meunier JP, Lemaire N, Bendjenana H. Acute respiratory illness as a trigger for detecting chronic bronchitis in adults at risk of COPD: a primary care survey. Prim Care Respir J. 2010 Dec;19(4):371-7. doi: 10.4104/pcrj.2010.00042.
- Background: PubMed 18048806Langsetmo L, Platt RW, Ernst P, Bourbeau J. Underreporting exacerbation of chronic obstructive pulmonary disease in a longitudinal cohort. Am J Respir Crit Care Med. 2008 Feb 15;177(4):396-401. doi: 10.1164/rccm.200708-1290OC. Epub 2007 Nov 29.
- Background: PubMed 21437566Gruffydd-Jones K, Loveridge C. The 2010 NICE COPD Guidelines: how do they compare with the GOLD guidelines? Prim Care Respir J. 2011 Jun;20(2):199-204. doi: 10.4104/pcrj.2011.00011.
- Background: PubMed 17975187Wilt TJ, Niewoehner D, MacDonald R, Kane RL. Management of stable chronic obstructive pulmonary disease: a systematic review for a clinical practice guideline. Ann Intern Med. 2007 Nov 6;147(9):639-53. doi: 10.7326/0003-4819-147-9-200711060-00009.
- Background: PubMed 21559550Postma D, Anzueto A, Calverley P, Jenkins C, Make BJ, Sciurba FC, Similowski T, van der Molen T, Eriksson G. A new perspective on optimal care for patients with COPD. Prim Care Respir J. 2011 Jun;20(2):205-9. doi: 10.4104/pcrj.2011.00041.
- BackgroundAlbert RK, Connett J, Bailey WC, Casaburi R, Cooper JAD, Criner GJ, Curtis JL, Dransfield MT, Han M, Lazarus SC, Make B, Marchetti N, Martinez FJ, Madinger NE, McEvoy C, Niewoehner DE, Porsasz J, Price CS, Reilly J, Scanlon PD, Sciurba FC, Scharf SM, Washko GR, Woodruff PG, and Anthonisen NR for the COPD Clinical Research Network. Chronic Administration of Azithromycin Decreases the Frequency of Chronic Obstructive Pulmonary Disease Exacerbations. Results of a Randomized Trail. NEJM 2011. In Press.
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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.
Fernando J Martinez, MD, MS principal investigator
University of Michigan
Nancy K Leidy, PhD principal investigator
United BioSource, LLC
David Mannino, MD principal investigator
University of Kentucky
4 sites 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 (COPD), run by University of Michigan at 4 sites 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 2 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
COPD Case Finding Tool (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880177, which also lists 31 linked publications.
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 11 May 2016.