Michigan Early Disease Progression Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-30

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Recognition of Early Pulmonary Structural Changes by Using Real-time High Fidelity Expiratory CO2 Analysis

NCT05092035

COPD ILD

COMPLETED NA

Non-contact Proactive Remote Monitoring of COPD Exacerbations

NCT05598983

COPD Exacerbation

RECRUITING

Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints

NCT00292552

Pulmonary Disease, Chronic Obstructive

COMPLETED

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

NCT03014609

Chronic Obstructive Pulmonary Disease

RECRUITING

Genomic/ Proteomic/ Metabonomic Profiling in Chronic Obstructive Pulmonary Disease (COPD)

NCT00655694

Pulmonary Disease, Chronic Obstructive

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No