Michigan Early Disease Progression Cohort

NCT04968249 | Active Not Recruiting

• 1 other identifier: HUM00176147
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COPD

Keywords

Early COPD; COPD; Smoking; CAPTURE; RETHINC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Radiographic abnormalities on baseline CT

  3 years

Study Arms (4)

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

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

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

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

Interventions

Observational OTHER

Observational Cohort to understand risk factors for early COPD.

Gold 0; Gold 1; Gold 2; Preserved Ratio Impaired Spirometry (PRISm)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 29406779 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and nasal swabs.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• MeiLan Han

  University of Michigan, Michigan Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: July 30, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)