Michigan Early Disease Progression Cohort

Active, not recruiting

• Conditions: COPD
• Interventions: Other: Observational

• Registration Number: NCT04968249
• Lead Sponsor: University of Michigan

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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-20
• Study Start: 2021-07-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gold 0	Observational	Participant must be ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 ≥ 80% predicted.
Gold 2	Observational	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.
Gold 1	Observational	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.
Preserved Ratio Impaired Spirometry (PRISm)	Observational	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States