This study is not recruiting at this time. Please visit the site again for recruiting updates.
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 |
