Asthma Clinical Research Network (ACRN)

BACKGROUND:

Asthma is an increasingly serious cause of morbidity and mortality in the United States. There are approximately 12 million asthmatics, and the disease affects both sexes and impacts all racial and ethnic groups. It is now recognized that asthma is a complex disease of varied etiology, which is triggered by a number of factors (e.g., allergens, drugs, chemicals, exercise, cold air, infections, and emotions), making asthma therapy difficult and sometimes complicated. Multiple drugs, including medications to treat and control symptoms (bronchodilator agents such as beta-adrenergic agonists, theophylline, and anticholinergics) and medications thought to control underlying airway inflammation (e.g., inhaled and systemic corticosteroids, cromolyn sodium, and nedocromil), are often required.

Despite major advances in the understanding of the etiology and pathophysiology of asthma and the development of new therapeutic modalities, the prevalence, severity, and mortality from asthma in all age groups have increased over the past decade. Mortality rates are disproportionately high in urban and rural minority populations. Hospitalizations for asthma have doubled in adults and increased five-fold for children over the past 20 years. Asthma continues to place a heavy burden on patients and their families, the health care system, and society as a whole. Therefore, new approaches are needed to help alleviate this growing problem.

A particularly important need at this juncture is a mechanism for the rapid evaluation of new and existing therapeutic approaches for asthma and for the dissemination of laboratory and clinical findings to the health care community. The Asthma Clinical Research Network (ACRN) program seeks to accomplish this through the development of a network of interactive asthma clinical groups that conduct clinical studies employing common protocols in a coordinated and multidisciplinary setting. This will ensure ready access to an adequate number of well characterized patients from diverse populations and age groups. It will also bring together and coordinate the necessary clinical expertise and administrative resources to conduct multiple therapeutic studies. Centralized protocols will promote high quality design, decrease the variability in supportive modalities, and reduce the redundant utilization of resources required for rapidly conducting multiple independent clinical studies. The separate data coordinating center supports protocol and questionnaire development, sample size calculations, complete data analysis, and overall study coordination.

The initiative was developed by the Pulmonary Diseases Advisory Committee working group, approved by the full committee at the February 1992 meeting, and given concept clearance by the National Heart, Lung, and Blood Institute (NHLBI) Advisory Council in May 1992.