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NCT04968249

Michigan Early Disease Progression Cohort

Sponsor: University of Michigan

View on ClinicalTrials.gov

Summary

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).

Official title: Michigan eArly Disease Progression Cohort in COPD (MAP COPD)

Key Details

Gender

All

Age Range

30 Years - 55 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2021-07-30

Completion Date

2027-03

Last Updated

2025-06-25

Healthy Volunteers

Conditions

COPD

Interventions

OTHER

Observational

Observational Cohort to understand risk factors for early COPD.

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States