Intervention with once-daily budesonide reduces long-term risk and frequency of severe asthma-related events

Mar 21 2005

New data indicated that earlier intervention with once-daily budesonide, an inhaled corticosteroid delivered by dry powder inhaler to children with mild persistent asthma, significantly reduced the long-term risk and frequency of severe asthma-related events as well as the need for other inhaled medication.

The findings, presented at the 61st annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), are from two analyses of the Inhaled Steroid as Regular Therapy in Early Asthma (START) study, a three-year trial involving nearly 2,000 children aged 5 to 10 years with mild persistent asthma. The START study was funded by AstraZeneca.

"Many children with asthma make repeated trips to the emergency room or are hospitalized because of worsening symptoms," said Dr. Albert Sheffer, Clinical Professor of Medicine at Harvard Medical School, Director Emeritus at the Allergy Clinic, Brigham and Women's Hospital in Boston and an investigator in the safety and tolerability portion of the study. "The findings of these two analyses showed that budesonide had a viable long-term treatment effect."

In the first analysis, 1,974 children were randomized to receive either once-daily budesonide or placebo in addition to usual asthma care. The earlier use of budesonide reduced the risk of exacerbation, or severe asthma related events by 40 percent compared to usual asthma care. In addition, children in the budesonide group required fewer interventions with other inhaled corticosteroids (12.3 percent versus 22.7 percent for placebo), and had improved lung function.

The second analysis tracked the adverse side effects reported by 1,981 children taking either budesonide plus usual care or placebo over three years. Overall, the incidence of side effects was comparable between the two groups, with fewer asthma exacerbations and adverse events reported in the budesonide group throughout the study (budesonide 43.8%; usual care 42.8%). The most frequently reported adverse events were respiratory infection, pharyngitis, rhinitis, viral infection and bronchitis.

Asthma is one of the most serious chronic medical conditions in the United States. In 2002, it was estimated that 20 million Americans have asthma. Of these, nearly 12 million Americans had an asthma attack or episode in the past year. Additionally, it is estimated that more than 30 million Americans, or about 10 percent of the U.S. population, have been diagnosed with asthma at some point in their lives.

Asthma is a reversible obstructive lung disease, caused by increased reaction of the airways to various stimuli, such as cigarette smoke, airborne molds, pollens, dust, animal dander, exercise, cold air, many household and industrial products, air pollutants, scents or simple stress. It is a chronic inflammatory condition that usually leads to breathing problems known as "episodes" – a series of events that result in narrowed airways – which is responsible for the difficulty in breathing with the familiar wheeze. Although each person reacts differently to the factors that may trigger asthma, it can be a life-threatening disease if it is not properly managed. According to the American Lung Association, more than 4,200 Americans died from asthma in 2001.