Breath of Fresh Air: Feature Articles

Chapter 14: Asthma Clinical Research Network

Modern asthma research advances on many fronts. Basic science research attempts to identify the causes and mechanisms of asthma; epidemiologic research studies the course of the disease over time and trends in its frequency and severity. Pharmaceutical companies sponsor research into new drug therapies for asthma and allergies, and clinical investigators at hospitals and medical centers conduct experiments into how best to use various treatments in the management of asthma. At the Brigham and Women's and Massachusetts General Hospitals, asthma research is conducted in all of these areas.

Many types of asthma research projects are being conducted.

However, some experiments involving persons with asthma need large numbers of subjects to participate in order to answer important questions. One specific example can illustrate this point. In the early 1990's some asthma researchers in New Zealand reported the results of an experiment that they had conducted regarding the regular use of beta-agonist inhalers. Beta agonists are the quick-acting bronchodilators such as albuterol, pirbuterol or metaproterenol (brand names: Proventil®, Ventolin®, Maxair®, Alupent®, and Metaprel®). These researchers reported that regular use of a beta-agonist inhaler (taken two inhalations four times a day) led to worse control of asthma than use of the beta-agonist inhaler taken only when needed for relief of the symptoms of asthma. Their study was conducted among 54 persons with asthma and used a beta-agonist medication not available in the United States, called fenoterol.

The results of this study (and some others reported around the same time) raised serious concerns about how we treat asthma. Physicians wondered whether their prescriptions for beta agonists were causing harm rather than good if patients were using the medications on a regular four-times-a-day basis. Others were skeptical of the results of the New Zealand study and doubted that they applied to other beta agonists. To answer this question without any doubt would require several hundred patients with asthma, and it would probably best be done by research that was not supported by a pharmaceutical company (which might have special interest in the outcome of the study). No single hospital or asthma center would have the financial resources or a sufficient number of patients willing to volunteer to conduct a study of this magnitude, despite its importance to millions of persons with asthma.

There is a need for large-scale, clinical trials not sponsored by pharmaceutical firms.

Fortunately, federal government, through its National Institutes of Health, recognized the need for large-scale, impartial clinical studies into the management of asthma. In 1993 it organized a research network of five major asthma centers across the nation to collaborate in clinical asthma studies. The centers were chosen on the basis of their expertise, past experience, and resources enabling them to conduct research of this sort. By working together, they have the means to answer important questions about asthma care that no one center could address on its own. The Brigham and Women's Hospital was chosen to participate as one of these five centers, collaborating in the Asthma Clinical Research Network.

Brigham and Women’s Hospital was chosen to participate in a collaborating group of reseach centers, the Asthma Clinical Research Network.

Too often research involving persons with medical illnesses have been criticized for recruiting predominantly white men as research subjects. The population of patients in clinical trials should reflect the diversity of persons who have the disease. The Asthma Clinical Research Network has made a special effort to include women and persons of color in their experiments. In addition, a sixth site (Harlem Hospital in New York) was included, facilitating participation in these studies by persons of color.

The first clinical study designed and performed by the participating centers of the Asthma Clinical Research Network addressed the question of the safety and effectiveness of regular versus as needed use of the beta-agonist inhaler, albuterol. Drs. Jeffrey Drazen and Elliot Israel of the Partners Asthma Center took the lead in this important research. More than 250 persons with mild asthma entered into this 16-week research project. Fifty-six percent of the participants were women; 33% were minority. A report describing the results of this study was published in the prestigious New England Journal of Medicine [and is discussed briefly in Chapter 8 of this book]. They found no differences between the group of patients using their beta-agonist inhaler regularly four times each day and the group using their inhaler only as needed. Regular use of an albuterol inhaler in mild asthma was neither harmful nor helpful. Fears about the dangers of regular use were allayed, and at the same time the recommendation to use the beta-agonist bronchodilators only if needed to relieve symptoms was reinforced.

Additional research studies in asthma management have been completed by the Asthma Clinical Research Network. Others are being conducted now; still other are being planned for the years ahead. By providing knowledge to help guide the way in which asthma is treated, these studies will have a major impact on the lives of millions of people. The Partners Asthma Center is proud to include the Asthma Clinical Research Network as one of its asthma research activities.

If you wish more information about asthma research studies being conducted by the Asthma Clinical Research Network at Brigham and Women’s Hospital, call (617) 732-8260.

The first study of this research network addressed the question of whether regular use of inhaled beta-agonist bronchodilators might be harmful.