Michigan Early Disease Progression Cohort (MAP_COPD)

• ClinicalTrials.gov Identifier: NCT04968249
• Recruitment Status: Active, not recruiting
• First Posted: July 20, 2021
• Last Update Posted: May 2, 2024
• Sponsor: University of Michigan
• Information provided by (Responsible Party): MeiLan Han, University of Michigan

Study Description

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).

Condition or disease	Intervention/treatment
COPD	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 Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Michigan eArly Disease Progression Cohort in COPD (MAP COPD)
• Actual Study Start Date: July 30, 2021
• Estimated Primary Completion Date: July 2024
• Estimated Study Completion Date: July 2024

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. CAAT score ≥ 10 [ Time Frame: 3 years ]
   Proportion of individuals with CAAT score ≥ 10
2. Exacerbations in the prior year [ Time Frame: 3 years ]
   Frequency of moderate and severe exacerbations in the prior year measured at baseline

Secondary Outcome Measures :

1. Radiographic abnormalities on baseline CT [ Time Frame: 3 years ]
   Proportion of individuals with radiographic abnormality on baseline CT defined as PRMfSAD≥15% and/or PRMEmph ≥3%

Biospecimen Retention:   Samples With DNA

Serum, plasma, and nasal swabs.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: MeiLan Han; University of Michigan, Michigan Medicine

More Information

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. Erratum In: Am J Respir Crit Care Med. 2018 Dec 1;198(11):1463.

• Responsible Party: MeiLan Han, Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT04968249
• Other Study ID Numbers: HUM00176147
• First Posted: July 20, 2021
• Last Update Posted: May 2, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MeiLan Han, University of Michigan:

Early COPD; COPD; Smoking; CAPTURE; RETHINC

Additional relevant MeSH terms:

Disease Progression; Disease Attributes; Pathologic Processes