Michigan Early Disease Progression Cohort (MAP_COPD)

Michigan eArly Disease Progression Cohort in COPD (MAP COPD)

The aim of this project is to develop a disease progression cohort within the University of Michigan Health System to capture pulmonary function, symptom assessments and quantitative imaging among patients at risk for or with an established diagnosis of COPD, focusing however on "early" COPD (age 30-55 and GOLD stage 0,1, 2, and prism).

Study Overview

• Status: Active, not recruiting
• Conditions: COPD
• Intervention / Treatment: Other: Observational

Detailed Description

Participants between the ages of 30-55 with at least 10 pack-year smoking history will be enrolled into a observational longitudinal cohort.

During the course of the study, additional funding was secured, so data could be collected for a 3-year period from participants. Some of the cohort are co-enrolled in another study (NCT05033990) where they received a CT scan as part of the study. Those participants will not be re-scanned during the course of this study.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients meeting inclusion criteria who have established disease as well as smokers meeting inclusion criteria where pulmonary function testing has not been performed.

Description

Inclusion Criteria:

• GOLD 0 Participant must be ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 ≥ 80% predicted.
• Preserved Ratio Impaired Spirometry (PRISm) participants shall be between ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV150-79% predicted and FEV1/FVC > 0.70.
• GOLD 1 participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 >= 80% predicted. OR
• GOLD 2 participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 50-79% predicted.

Exclusion Criteria:

• 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). We 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 at the time of the baseline or return visits. This special population is being excluded to minimize potential for fetal radiation exposure.
• Cognitive dysfunction that prevents the participant from completing study procedures.
• BMI > 35.0 kg/m2 at baseline, due to the effects of body weight on CT scan imaging quality.
• 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).
• 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 image quality.
• History of thoracic radiation or thoracic surgery with resection of lung tissue

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gold 0; Participant must be ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 ≥ 80% predicted.	Other: Observational; Observational Cohort to understand risk factors for early COPD.
Gold 1; Participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 >= 80% predicted.	Other: Observational; Observational Cohort to understand risk factors for early COPD.
Gold 2; Participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 50-79% predicted.	Other: Observational; Observational Cohort to understand risk factors for early COPD.
Preserved Ratio Impaired Spirometry (PRISm); Participant shall be between ages 30-55 years and have: ≥10 year smoking history, post-bronchodilator of FEV1 50-79% predicted and a predicted FEV1/FVC ≥ 0.70.	Other: Observational; Observational Cohort to understand risk factors for early COPD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAAT score ≥ 10	Proportion of individuals with CAAT score ≥ 10	3 years
Exacerbations in the prior year	Frequency of moderate and severe exacerbations in the prior year measured at baseline	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic abnormalities on baseline CT	Proportion of individuals with radiographic abnormality on baseline CT defined as PRMfSAD≥15% and/or PRMEmph ≥3%	3 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: MeiLan Han, University of Michigan, Michigan Medicine

Publications and helpful links

General Publications

• Martinez FJ, Han MK, Allinson JP, Barr RG, Boucher RC, Calverley PMA, Celli BR, Christenson SA, Crystal RG, Fageras M, Freeman CM, Groenke L, Hoffman EA, Kesimer M, Kostikas K, Paine R 3rd, Rafii S, Rennard SI, Segal LN, Shaykhiev R, Stevenson C, Tal-Singer R, Vestbo J, Woodruff PG, Curtis JL, Wedzicha JA. At the Root: Defining and Halting Progression of Early Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1540-1551. doi: 10.1164/rccm.201710-2028PP. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Smoking; Early COPD; CAPTURE; RETHINC
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: HUM00176147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No