Simpler Asthma Treatment Options Found Effective

American Lung Association Clinical Trial Tested Specific Drugs Head-to-Head with Gold Standard of Asthma Treatment

(May 16, 2007)

Editor’s Note: New England Journal of Medicine today launches interactive “Clinical Decisions” feature, based on a case study reflecting treatment implications presented in American Lung Association research. Readers review vignette and treatment options, and vote at www.nejm.org for one of three treatment options presented.

NEW YORK, NEW YORK, May 16, 2007—Results of American Lung Association clinical research published today in the New England Journal of Medicine found that a simpler, once-a-day regimen of a combination inhaler containing an inhaled corticosteroid and a long-acting beta-agonist is just as effective as twice-daily inhaled corticosteroid treatment in patients with mild persistent asthma, which may open the doors to more convenient treatment plans for millions of Americans.

“Effective, less intensive alternatives may lead to greater adherence among patients, which would mean better asthma control with a minimum of medication—the goal of asthma treatment,” said Norman H. Edelman, M.D., American Lung Association Chief Medical Officer.

“For patients, a simpler treatment plan means less drugs to take—and to remember to take—every day, fewer prescription refills and perhaps less money spent on medications, and fewer side effects. This is the kind of practical research that is helpful immediately for both physicians and patients alike.”

The study conducted by the American Lung Association’ Asthma Clinical Research Centers, the Leukotriene Modifier or Corticosteroid or Corticosteroid-Salmeterol (LOCCS) Trial compared alternative treatments among 500 adults and children whose mild persistent asthma was well controlled with standard asthma therapy (twice-daily low dose of an inhaled corticosteroid).  Subjects were assigned to one of three study groups: one that continued to take the inhaled corticosteroids (fluticasone) twice daily; one that took a combination inhaler containing an inhaled corticosteroid (fluticasone) and a long-acting (inhaled) bronchodilator (salmeterol) once-daily; and one that took the leukotriene modifier, montelukast (pill form) once-daily. Results showed that once-daily fluticasone plus salmeterol was as effective as twice-daily fluticasone treatment; oral montelukast taken once-a-day, however, was not as effective as the twice-daily inhaled corticosteroid treatment but did provide good control for most patients.

“The gold-standard for treatment of mild, persistent asthma is twice-a-day inhaled corticosteroids, but we found that patients doing well on that therapy may be able to step down to a more convenient, once-a-day alternative with no loss of asthma control,” explained Stephen P. Peters, MD, PhD, lead author of the study and Professor of Medicine & Pediatrics, Wake Forest University School of Medicine. “The good news is that most patients did pretty well in this trial no matter what treatment regimen they were on, so patients and physicians have more choices for safe, effective treatment and can make their choices based on what works best for the patient.”

More than 22 million Americans have asthma, which caused 1.8 million emergency room visits in 2004. While asthma attacks are caused by increased reaction of the airways to various stimuli, the inflammation underlying asthma is continuous. Medications help reduce airway inflammation and relieve or prevent symptomatic airway narrowing.

“It’s certainly easier to do something once a day rather than twice a day,” said Dr. Peters. “Now physicians can discuss reasonable alternatives for step-down treatment for patients who gain asthma control with standard therapy based on solid evidence from a randomized controlled clinical trial, which is the best way to evaluate and compare treatment alternatives.”

The American Lung Association Asthma Clinical Research Centers Network is the nation’s largest not-for-profit network of clinical research centers dedicated to asthma treatment research. The network’s mission is to conduct large clinical trials that will have a direct impact on patient care and asthma treatment.  The network consists of 20 asthma clinical research centers based at leading universities across the United States and a Data Coordinating Center managed by a team at Johns Hopkins University.   The network is currently conducting two clinical trials evaluating whether treatments for acid reflux are helpful for people with asthma that is difficult to control using standard therapies.  For details about current studies and a complete list of Asthma Clinical Research Centers, visit www.lung.org.

About the American Lung Association
Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates continue to increase while other leading causes of death have declined. The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is “Improving life, one breath at a time.” For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA (1-800-586-4872) or log on to www.lung.org.