NCT04968249Active, not recruiting
Michigan Early Disease Progression Cohort
Michigan eArly Disease Progression Cohort in COPD (MAP COPD)
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 8 Jul 2021
- Start date
- 30 Jul 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Michigan
- Diseases
- COPD
- NCT number
- NCT04968249
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 30 Jul 2021 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- History of thoracic radiation or thoracic surgery with resection of lung tissue
Other
- 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.
- Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.
Who the study is looking for
- 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.
Age in the registry: 30 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.