University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2

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 as part of the study to verify COPD status.

Eligibility

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:

  1. Prior Diagnosis of COPD in the EMR
  2. Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or
  3. LAA\>1% on lung cancer screening CT scan

Exclusion Criteria:

* 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.
* 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.

Conditions6

Locations1 site

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