Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).
BACKGROUND:
The prevalence, morbidity, mortality, and treatment cost of COPD are high and increasing.
COPD is the sixth leading cause of death worldwide and is the only condition in the top 10
causes of death that has an increasing prevalence and mortality. The cost of health care for
patients with COPD in the U.S. is approximately $6.5 billion per year; acute exacerbations
account for between 31% and 68% of that cost. Macrolide antibiotics may reduce the frequency
and/or severity of COPD exacerbations, as a result of their antibacterial properties and
anti-inflammatory effects. Long-term administration of macrolide antibiotics in patients with
a number of other pulmonary disorders has resulted in clinically important improvements. It
is hypothesized that administration of a macrolide antibiotic (azithromycin) for 1 year, when
added to usual care, will decrease the frequency and severity of COPD exacerbations. If this
hypothesis is correct, the proposed treatment is also expected to reduce the mortality of
COPD patients.
DESIGN NARRATIVE:
This is a prospective, randomized, double-blind, placebo-controlled study that will enroll
1130 patients with at least moderately severe COPD who, based on clinical indicators, have an
increased likelihood of experiencing an acute exacerbation during the study period. Patients
will be monitored monthly, including careful assessments of possible macrolide-related side
effects. The exclusion criteria for this study will include a variety of conditions or
medications that are known to adversely interact with macrolides. The primary endpoint of
this study is time until the first acute COPD exacerbation. The secondary endpoints include
macrolide-related side effects, the incidence of macrolide-resistant bacterial colonization,
quality of life, and cost-effectiveness.
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