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| Name | Class |
|---|---|
| COPD Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current Smoker | Participants that are currently smoking | ||
| Former Smoker | Participants that have at least 20 pack-years of smoking history |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Attenuation Area (LAA) Thresholds | Percentage of participants who meet spirometric criteria for COPD and have >1% LAA on lung cancer screening CT scan. | Baseline |
| Exacerbation risk and symptom burden |
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Inclusion Criteria:
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:
Exclusion Criteria:
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
Additional temporal exclusion criteria are as follows:
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Patients undergoing lung cancer CT scans are at high risk for having concurrent COPD.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
| 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% | Baseline |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |