Purpose of the Study. To determine the effectiveness of as-needed versus regular controller therapy in adults with mild persistent asthma.
Study Population. A total of 225 adults with symptom criteria for mild persistent asthma and forced expiratory volume in 1 second (FEV1) >70% predicted with >12% reversibility or PC20 (provocative concentration causing a 20% decrease in FEV1) methacholine at ≤16 mg/mL.
Methods. Patients were assigned to 1 of 3 treatment groups: budesonide DPI 200 μg twice daily (BUD), oral zafirlukast 20 mg twice daily (ZAF), or placebo. The study was double-blind, double-dummy. At the beginning and the end of the study, all patients were treated with 0.5 mg/kg per day of prednisone, 800 μg twice a day of budesonide, and 20 mg twice a day of zafirlukast plus as-needed albuterol. Evaluation was accomplished by assessing asthma symptoms followed by pulmonary-function testing and gathering information on, albuterol use and exacerbations over the 1-year study.
Results. For both of the primary efficacy outcomes, morning peak expiratory flow rate and exacerbations, there were no differences between the groups. Several outcomes were superior for the BUD group, including prebronchodilator FEV1, bronchial reactivity, symptom scores, exhaled nitric oxide, asthma control score, and symptom-free days (26 more). Postbronchodilator FEV1 and quality of life were not different between the groups. The as-needed group took budesonide, on average, for only one-half week during the study.
Conclusions. Adults with mild persistent asthma can be managed with high-dose budesonide on an intermittent basis. However, greater improvement in markers of airway inflammation and more symptom-free days (26 per year) occurred with regular use of low-dose budesonide.
Reviewer Comments. This is an adult study that focused on short-term outcomes, which may not translate to children. It is not known if similar results would be seen with a longer-term study.
- Copyright © 2006 by the American Academy of Pediatrics