IRB Number:

266-06

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

We are trying to determine if giving a daily antibiotic reduces the frequency and severity of COPD exacerbations(worsening of symptoms).

Who is Eligible to Participate in the Study?

1. Male and female subjects 40 years of age and older


2. Clinical diagnosis of at least moderate COPD:


• Postbronchodilator FEV1/FVC < 70%


• Postbronchodilator FEV1 < 80% predicted


3. Cigarette consumption of 10 pack-years or more. Subjects may or may not be active smokers.


4. Each subject must meet one or more of the following criteria:


• Be using supplemental oxygen or will have a history within the past year of


• Receiving a course of systemic corticosteroids for respiratory problems in the past year


• Visiting an Emergency Department for a COPD exacerbation within the past year or


• Being hospitalized for a COPD exacerbation within the past year


5. Be willing to make study visits and and phone calls.

Minimum Age:

40

Maximum Age:

100

What is Involved With this Study?

There will be 8 Clinic visits and between 7 and 11 telephone visits. At the Clinic visits they will have blood tests, pulmonary testing, ECG, audiograms(hearing tests), nasal swabs, a history and physical exam, questionnaires, and COPD education.

How long will the Study run?

Participants will be coming to the Clinic for visits over the course of 13 months. Then they will receive followup phone calls every 6 months until all participants have finished the active phase of the study.

Who can I Contact for Additional Information on this Trial?

June Hart
Mayo Clinic Pulmonary Research Center
507-284-9009 or 800-458-0956 FAX 507 266 4371
Monday-Friday 7:00-4:00

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/01/2006