Clinical Studies

The Division of Pulmonary & Critical Care Medicine conducts and participates in a number of clinical studies in the area of Chronic Obstructive Pulmonary Disease (COPD).

Losartan Effects on Emphysema Progressio (LEEP)

To measure the effect of Losartan on HRCT-measured emphysema progression at 48 weeks of drug (Losartan)/placebo. The study will measure the effect of Losartan on lung function (by spirometry and HRCT-measured lung volumes). The study will also explore sub-groups of interest for heterogeneity of treatment effects and determine the safety and tolerability of losartan in emphysema patients.

Inclusion Criteria:

  • Age of 40 years or older at V1, either gender
  • Mild to severe COPD (FEV1/FVC ratio ≤ 0.70, FEV1 30-70% predicted) at V1
  • Current or former smoker (≥ 10 pack-year history at V1)
  • HRCT Scan with 5-35% of voxels with density < -950 Hounsfield Units (HU) at V1

Redefining Therapy in Early COPD (RETHINC)

A 12-week multicenter, randomized, double-blind, placebo controlled, parallel-group study to assess the efficacy and safety of indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily in symptomatic current and former smokers with respiratory symptoms despite preserved spirometry as defined by CAT ≥ 10 and post-bronchodilator FEV1/FVC ratio ≥0.70.

Inclusion Criteria:

  •  Age 40-80
  •  ≥20 pack-year smoking history
  •  Post-bronchodilator FEV1/FVC ratio ≥0.70
  •  Baseline CAT≥10

INtervention Study in Overweight Patients with COPD (INSIGHT)

A multicenter, patient-level randomized, pragmatic clinical trial to produce first-ever data on the effectiveness of an evidence-based self-directed lifestyle intervention for 12 months targeting modest weight loss and increased physical activity among overweight and obese patients with COPD.

Inclusion Criteria:

  • 40 years or older
  • Body mass index 25.0-44.9 kg/m2
  • ≥ 10 pack-year smoking history
  • Modified Medical Research Council dyspnea score of 2 or higher
  • COPD, defined as an FEV1/FVC less than the lower limit of normal and FEV1% predicted greater than 40
  • Access to DVD player or internet in order to view the 12 GLB sessions

Beta-Blockers for the Prevention of Acute Exacerbations of COPD (BLOCK COPD)

This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that will enroll 1028 patients with at least moderately severe COPD over a three-year period and follow them at regular intervals for one year. The primary endpoint is time to first acute exacerbation. Secondary endpoints include rates and severity of COPD exacerbations, cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life, and metoprolol-related side effects.

Inclusion Criteria:

  • Male and female subjects, ≥ 40 and less than 85 years of age
  • Clinical diagnosis of at least moderate COPD; Post bronchodilator FEV1/FVC < 70%, Post bronchodilator FEV1 < 80% predicted
  • Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers
  • To enrich the population for patients who are more likely to have acute exacerbations (54), each subject must meet one or more of the following 4 conditions:
    • Have a history of receiving a course of systemic corticosteroids or antibiotics for respiratory problems in the past year, or
    • Visiting an Emergency Department for a COPD exacerbation within the past year, or
    • Being hospitalized for a COPD exacerbation within the past year, or
    • Be using or be prescribed supplemental oxygen for 12 or more hours per day
  • Willingness to make return visits and availability by telephone for duration of study

APR Registry

To develop a registry of patients with airways disease within the American Lung Association Airways Clinical Research Network (ALA-ACRC).

All patients contacted by the participating clinics with a physician diagnosis of asthma, COPD or ACOS can be enrolled, regardless of whether they are enrolled in individual study protocols of the ALA-ACRC network. Males and females of all ages will be eligible.

 
For more information regarding the above clinical studies, please send an email to copd-research@med.umich.edu or visit: