BETHESDA, MD—The National Asthma Education and Prevention Program (NAEPP) recently issued an update to the Guidelines for the Diagnosis and Management of Asthma.[1] Of particular note are its new recommendations for the long-term management of asthma in children.

“This update is very important for pediatricians, primary care physicians, family physicians, and other health care practitioners who deal with the young population,” said Stuart Stoloff, MD, one of the authors of the 2002 update. He added that asthma therapy issues are most critical in young children and that the update seeks to address “the best therapy: in whom it should be used, and how it should be used.”

The NAEPP, which is coordinated by the National Heart, Lung, and Blood Institute (NHLBI), convened an expert panel to review the results of research from the past five years and to make appropriate changes in treatment protocols. The panel’s new recommendations are summarized here.

INHALED STEROIDS—MISUNDERSTOOD AND UNDERUSED

The guidelines suggest that long-term inhaled corticosteroids are best for controlling moderate to severe asthma in young children. The use of these drugs in children has been controversial because of the perceived risks—chiefly growth inhibition, decreased bone mineral density, and ocular disorders (eg, glaucoma).

In an interview with RESPIRATORY REVIEWS, Dr. Stoloff noted that among clinicians there is significant reluctance to prescribe inhaled corticosteroids. “Physicians do not understand the drugs. Parents and patients do not understand the drugs. There is concern among pediatricians that long-term corticosteroid therapy is detrimental. But they are not distinguishing between oral and inhaled corticosteroids.” As a result, many children do not receive adequate treatment for asthma.

Virginia Taggart, MPH, Health Scientist Administrator with the Division of Lung Diseases at NHLBI, agreed, noting that “the general background of reluctance on the pediatricians’ part may stem from the fact that oral steroids have known and documented side effects.”

“I believe this situation is changing, but not as quickly as it should,” said Dr. Stoloff, who is Clinical Professor of Family and Community Medicine at the University of Nevada School of Medicine in Reno. “Inhaled corticosteroids are very, very safe—both short and long term.”

EFFECTIVE LONG-TERM CONTROL

Cumulative data have suggested that low to medium doses of inhaled corticosteroids in children have the potential to cause a slight reduction in the rate of vertical growth, but this effect is neither sustained nor progressive. Studies have also shown that inhaled corticosteroids do not adversely affect bone mineral density, and using these drugs does not increase the incidence of cataracts or glaucoma.

According to the expert panel, trials that followed children for as long as six years demonstrated that inhaled corticosteroids do not pose clinically significant health risks. Improvement in both symptom scores and frequency was greater with inhaled corticosteroids than with ß2-agonist monotherapy. In fact, the lack of adverse effects and the degree of improvement in health outcomes for young children with persistent asthma are what led to the recommendation that inhaled corticosteroids be the preferred treatment in this age-group.

Dr. Stoloff stressed the need for long-term therapy in children. “Currently, asthma in children is being treated episodically,” he explained. “A child who has an asthmatic event is treated for that event, usually with either inhaled corticosteroids or a ß2-agonist. What these children really need is to be evaluated for long-term control therapy.”

Asthma is a chronic disease. “Physicians need to think of asthma exacerbations as part of a lifelong condition rather than a snapshot,” Dr. Stoloff said. Patients with persistent asthma need daily medication—even when they are not experiencing symptoms.

ß2-AGONISTS AND CORTICOSTEROIDS

For adults and children older than 5 years with moderate persistent asthma, the expert panel recommends that long-acting inhaled ß2-agonists be used as an adjunct to inhaled corticosteroids. When treatment with low to medium doses of inhaled corticosteroids alone is insufficient, adding a ß2-agonist to the therapeutic regimen can improve lung function and reduce symptoms. For this age-group, combination therapy is more effective than simply increasing the dose of inhaled corticosteroids.

In children younger than 5 years, moderate persistent asthma may be treated by adding a long-acting inhaled ß2-agonist to a low dose of inhaled corticosteroids or by using a medium dose of inhaled corticosteroids as monotherapy.

CAN EARLY TREATMENT ALTER DISEASE PROGRESSION?

The expert panel revised its position on the progression of asthma. The guidelines now state that for children ages 5 to 12 years with mild or moderate persistent asthma, treatment with inhaled corticosteroids provides control but does not alter the course of the underlying disease; symptoms tend to return when the drugs are discontinued. It also notes that there is currently no evidence that such children suffer a progressive loss of lung function, with or without treatment.

In contrast, studies have shown that in younger children with asthma, a loss of lung function can occur during the first three to five years of life; loss of lung function can also develop rapidly in adults. It is not yet clear whether these decreases in lung function can be prevented with appropriate therapy, but early treatment should at least improve quality of life. Thus, Dr. Stoloff said that physicians need to find better ways to identify children within the first three years of the onset of asthma symptoms—which, for some children, is the first three years of life.

PEAK STUDY RESULTS

According to the expert panel, there are no adequate studies of the effect of inhaled corticosteroids on preservation of lung function early in life. However, NHLBI is currently funding a double-blind, randomized, controlled, parallel-comparison study evaluating inhaled fluticasone against placebo in children ages 2 to 4 years who are at high risk of developing asthma.[2]

The study includes an “off” year, when the active treatment group will be taken off the study drug. This non-drug year is critical to determine whether or not treatment with inhaled corticosteroids has modified the disease course.

The investigators believe that administration of long-term inhaled fluticasone will modify the development of asthma, resulting in a significant decrease in prevalence and symptoms during the year without treatment. This remains to be proved, however.

If successful, the PEAK study will affect the way that asthma is managed in early childhood—specifically, by demonstrating the importance of early identification and aggressive treatment of children at high risk for the disease.

The trial began recruitment on January 1, 2001, and will be completed by September 1, 2004.

 

Summary of Revised Guidelines

The National Asthma Education and Prevention Program expert panel’s recommendations to modifying therapy for long-term management of mild to moderate persistent asthma in children are as follows: • The use of inhaled corticosteroids has been shown to improve control without negative effects, and the panel endorses corticosteroid therapy. • For adults and children older than age 5, combination therapy should include a long-acting inhaled b2-agonist plus low to medium doses of an inhaled corticosteroid. • For children younger than age 5, combination therapy should include a long-acting inhaled ß2-agonist plus a low dose of an inhaled corticosteroid or a medium dose of an inhaled corticosteroid alone.

—Gale Jurasek