• Vary with protocol
  

BACKGROUND:

COPD is a serious public health problem that is responsible for more than 500,000 hospitalizations, 100,000 deaths, and $15 billion in direct costs of medical care in the United States each year. In addition, millions of Americans are disabled by this disease. While smoking cessation is of clear benefit in slowing the progressive loss of lung function that is characteristic of COPD, management of established disease is largely limited to supportive measures that do not interfere with the disease process itself. More effective management strategies are needed. There is particular need for better prevention and management of exacerbations of COPD since these are associated with a substantial portion of the hospitalizations, deaths, and costs of care attributable to the disease. While certain supportive measures (such as long-term oxygen therapy) are of established benefit in selected patients, considerable uncertainty remains regarding the effectiveness of many treatment modalities that are routinely used in COPD, indications for specific therapies, the usefulness of novel therapeutic approaches, and the best means for management of common comorbid conditions.

The Request for Applications was released in August 2002.

DESIGN NARRATIVE:

Ambulatory Oxygen: a protocol to study possible benefits of providing ambulatory oxygen using a lightweight portable source was developed, approved, and implemented. Enrollment has begun. Primary outcome is oxygen usage. Secondary outcome is activity. See NCT00325754 for more information.

Macrolide Azithromycin: a protocol to evaluate the efficacy of the macrolide azithromycin for prevention of exacerbations has been developed and recommended for approval. An estimated 1,130 patients will be recruited.

Primary outcome is time till first exacerbation. Secondary outcomes include hospitalizations, quality of life, and incidence of macrolide-resistant bacterial colonization. See NCT00325897 for more information.