CLINICAL QUESTION

In people 12 years and older with poorly controlled mild asthma, is as-needed use of a fixed-dose combination of budesonide and albuterol superior to albuterol alone?

BOTTOM LINE

For patients with mild but poorly controlled asthma, the use of a combination rescue inhaler (albuterol plus budesonide) resulted in fewer exacerbations than albuterol alone. (Level of Evidence = 1b)

SYNOPSIS

The study included 2,516 participants 12 years and older; at baseline, 74% were taking a short-acting beta2 agonist (SABA), such as albuterol alone, and 26% were using the SABA in combination with an inhaled corticosteroid or a leukotriene antagonist. All participants reported that their asthma was not well controlled or was very poorly controlled on a standard questionnaire. The mean age of the participants was 42 years (only 3% were adolescents), 30% were non-White, two-thirds were female, and 11% had experienced a severe exacerbation in the previous year. Groups were balanced at baseline, and although the primary analysis used the per-protocol population, results for the intention-to-treat analysis were also reported (and were similar). Participants could continue any maintenance therapy they were using at baseline (randomization was stratified by baseline medications) but they were randomized to use two puffs of budesonide 80 mcg plus albuterol 90 mcg or two puffs of albuterol 90 mcg alone from a rescue inhaler. Patients could take up to 6 doses (12 puffs) in a 24-hour period.