Study Completed

For many years, doctors have suspected that certain bacterial infections may help cause COPD exacerbations. The MACRO Study is a clinical trial designed to determine whether azithromycin, an antibiotic, is effective in reducing the number or severity of COPD exacerbations.

What is Azithromycin?
Azithromycin is a member of a group of antibiotics called macrolides. For many years doctors have suspected that certain bacterial infections may help cause COPD exacerbations. Azithromycin is effective against the types of bacteria thought to be involved in these exacerbations. Azithromycin also has anti-inflammatory properties that might also help in reducing the number or severity of COPD exacerbations. This study was designed to scientifically test the effectiveness of azithromycin in treating COPD.

Who is eligible to participate?
Eligible CCRN participants:

  • Male and female subjects 40 years old or older
  • Have moderate-to-severe COPD
  • Either currently smoke or previously smoked
  • Do not have a hypersensitivity to certain types of antibiotics
  • Do not have medical conditions or take medications that would negatively interact with the azithromycin antibiotic, such as Cisapride, Cafergot, Pimozide, Disopyramide, Cyclosporin, Tacrolimus, Nelfinavir, Bromocriptine and Hexobarbital
  • Be willing to make return visits and be available by telephone for the duration of the study

Other factors, which may require testing, are also considered.

How many people will participate in the study and for how long?
1130 patients across the country will be enrolled in the research study for 13 months.

How does the study work?
The initial visit will determine whether you will be able to participate in this study. You will have a physical exam, blood tests, hearing and lung tests, an electrocardiogram, and a sputum or nasopharyngeal culture. Results from these tests will determine whether you can enter the treatment phase of the study. You will be asked questions about your medical history, medications, and some personal information (like your primary doctor and emergency department contact information). You will be asked to complete a variety of questionnaires about your quality of life.

One-half of the patients who participate will be given azithromycin. The other half will be given a placebo (no active medication). The treatment you receive will be determined by chance. Neither your doctor nor the research staff will know whether you are being given the azithromycin or the placebo.

Once in the treatment phase, you will visit the study office seven times over 13 months. You will also participate in seven phone calls with research staff, during which you will be asked questions about your health. The purpose for these visits and phone calls is to update health information and monitor for any side effects related to taking the azithromycin.

Additional information can also be found at the following Website:

http://www.clinicaltrials.gov/ct/show/NCT00325897?order=1

ClinicalTrials.gov Identifier: NCT00325897