COPD (Chronic Obstructive Pulmonary Disease)MAP2NCT07482475
University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Cancer Lung Screening, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to obtain new knowledge regarding screening for COPD. This study will use a participant's cancer screening CT scans performed as part of routine health care among current and former smokers at risk for COPD to identify participants who have had a spirometry or will have a spirometry test… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Cancer Lung Screening, Smoking Cigarette
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lung cancer CT scans are at high risk for having concurrent COPD.
Who may be able to join
- Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent.
- Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials.
- Ability to tolerate study procedures.
- Ability to provide informed consent.
- Clinical Lung Cancer Screening CT performed at the University of Michigan within the last year
- Meets one of the three following criteria:
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- Prior Diagnosis of COPD in the EMR
- Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or
- LAA>1% on lung cancer screening CT scan
Who cannot join
- The presence of a respiratory condition other than COPD or asthma, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g. dyspnea or decreased exercise tolerance).
- Severe asthma, which is defined as any of the following:
- Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = >250 fluticasone propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). The investigators will accept low-dose ICS/LABA or medium dose ICS.
- or 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or One asthma hospitalization in the past 12 months
- Concurrent participation in a therapeutic trial where treatment is blinded.
- Active pregnancy. Documentation of birth control will be required for pre-menopausal women.
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- Cognitive dysfunction that prevents the participant from completing study procedures.
- BMI > 35 kg/m2 at baseline, due to the effects of body weight on CT scan quality.
- Current illicit substance abuse, including cannabis smoking.
- Any illness expected to cause mortality in the next 3 years.
- Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan quality.
- History of thoracic radiation or thoracic surgery with resection of lung tissue.
- Additional temporal exclusion criteria are as follows:
- Participants who present with an acute exacerbation of COPD, either solely participant-identified or that has been clinically treated, in the last 30 days can be rescreened for the study once the 30-day window from end of drug therapy has passed.
- Participants who present with current use of acute antibiotics or steroids can be rescreened for the study ≥30 days after discontinuing acute antibiotics/steroids. This restriction does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Gretchen Bautisita, 734-764-8146, genvalen@med.umich.edu
Stacey Anderson, MPH, 2482149648, staceaan@med.umich.edu
About this study
The purpose of this study is to obtain new knowledge regarding screening for COPD. This study will use a participant's cancer screening CT scans performed as part of routine health care among current and former smokers at risk for COPD to identify participants who have had a spirometry or will have a spirometry test as part of the study to verify COPD status.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cigarette Smoking
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 Smoker | Participants that are currently smoking | |
| Former Smoker | Participants that have at least 20 pack-years of smoking history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD
All participants in this study must have had a previous lung cancer screening CT scan as part of their normal medical care within one year of enrolling in this study. These pre-enrollment scans will be evaluated to determine how many scans that had been intended to identify lung cancer also indicate COPD.
Measured: Baseline
Secondary outcomes (3)
Lung Attenuation Area (LAA) Thresholds
Percentage of participants who meet spirometric criteria for COPD and have >1% LAA on lung cancer screening CT scan.
Measured: Baseline
Exacerbation risk and symptom burden
Participants will report how they experience their pulmonary health using the COPD Assessment Test (CAT) survey. The CAT is comprised of 8 questions which are each rated on a scale of 0-5, with 0 indicating no symptoms and 5 indicating worst symptoms. Ratings are then summed to generate a total score, between 0-40, with 40 indicating worst symptoms.
The investigators will utilize data from the COPD Assessment Test (CAT) to describe and gain a deeper understanding of participants' symptom and exacerbation burden within this study population.
Measured: Baseline
Severity of COPD
Participants will be categorized into one of four GOLD categories based on their FEV1 values determined by a Pulmonary Function Test (PFT). If participants have had a PFT within the previous year, data from that test will be used. Otherwise, participants will be given a PFT during the study.
GOLD I (Mild COPD) = FEV1 >= 80% GOLD II (Moderate COPD) = 50% <= FEV1 < 80% GOLD III (Severe COPD) = 30% <= FEV1 < 50% GOLD IV (Very Severe COPD) = FEV1 < 30%
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- COPD Foundation
- Responsible party
- Principal investigator, MeiLan Han, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482475
- Sponsor's protocol ID
- HUM00271924
- Acronym
- MAP2
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
- ClinicalTrials.gov ID
- NCT07482475
- Acronym / sponsor ID
- MAP2 / HUM00271924
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- COPD Foundation
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- 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 study is to obtain new knowledge regarding screening for COPD. This study will use a participant's cancer screening CT scans performed as part of routine health care among current and former smokers at risk for COPD to identify participants who have had a spirometry or will have a spirometry test as part of the study to verify COPD status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Smoker | – | –Participants that are currently smoking |
| Former Smoker | – | –Participants that have at least 20 pack-years of smoking history |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lung cancer CT scans are at high risk for having concurrent COPD.
Key inclusion criteria (9 listed)
- Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent.
- Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials.
- Ability to tolerate study procedures.
- Ability to provide informed consent.
- Clinical Lung Cancer Screening CT performed at the University of Michigan within the last year
Key exclusion criteria (15 listed)
- The presence of a respiratory condition other than COPD or asthma, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g. dyspnea or decreased exercise tolerance).
- Severe asthma, which is defined as any of the following:
- Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = >250 fluticasone propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). The investigators will accept low-dose ICS/LABA or medium dose ICS.
- or 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or One asthma hospitalization in the past 12 months
- Concurrent participation in a therapeutic trial where treatment is blinded.
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
Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD
Time frame: Baseline
All participants in this study must have had a previous lung cancer screening CT scan as part of their normal medical care within one year of enrolling in this study. These pre-enrollment scans will be evaluated to determine how many scans that had been intended to identify lung cancer also indicate COPD.
3 secondary outcomes
Lung Attenuation Area (LAA) Thresholds
Time frame: Baseline
Exacerbation risk and symptom burden
Time frame: Baseline
Severity of COPD
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 (Chronic Obstructive Pulmonary Disease) and Cancer Lung Screening, run by University of Michigan 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD (time frame: Baseline). 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 Mar 2026.