Numerous changes have been incorporated into the new National Asthma Education and Prevention Program's Expert Panel Report 3. In the pharmacotherapy section of the report, many of these changes are minor in that they do not alter the basic philosophy of treatment recommendations from the previous Expert Panel Report but only add new formulations, change dosing or dosage forms, or add discussion of risks. However, 4 major changes have been identified, and the rationales for 3 are discussed in detail here. The treatment of childhood asthma is divided into 2 distinct age groups, infants less than 5 years of age and children 5 to 12 years of age, because of the availability of more data suggesting differences in response in these patients, as well as a relative paucity of quality data in the younger patients. Omalizumab, a humanized mAb to IgE, is the only new entity approved for the treatment of asthma since the previous guidelines, and its recommendations were reviewed. The indication for combination therapy with inhaled corticosteroids and long-acting inhaled beta(2)-agonists (LABAs) has been modified in lieu of the recent black box warning concerning the increased risk of severe asthma exacerbations and death associated with LABA use. However, the inhaled corticosteroids/LABAs are still recommended for patients with moderate-to-severe persistent asthma. The rationale for the continued recommendation is provided.