MAP_COPD: Michigan Early Disease Progression Cohort

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04968249
Collaborator
(none)
200
1
35.1
5.7

Study Details

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Michigan eArly Disease Progression Cohort in COPD (MAP COPD)
Actual Study Start Date :
Jul 30, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm 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 [18 months]

    Proportion of individuals with CAAT score ≥ 10

  2. Exacerbations in the prior year [18 months]

    Frequency of moderate and severe exacerbations in the prior year measured at baseline

Secondary Outcome Measures

  1. Radiographic abnormalities on baseline CT [18 months]

    Proportion of individuals with radiographic abnormality on baseline CT defined as PRMfSAD≥15% and/or PRMEmph ≥3%

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • GOLD 0 participants shall be ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC > 0.70 and FEV1 > 80% predicted; and COPD Assessment Test (CAT) score ≥ 10.

  • Preserved Ratio Impaired Spirometry (PRISm) participants shall be between ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1 < 80% predicted FEV1/FVC > 0.70.

  • GOLD 1-2 participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 50-80% 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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
MeiLan Han, Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT04968249
Other Study ID Numbers:
  • HUM00176147
First Posted:
Jul 20, 2021
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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, Professor, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2022