Beasley R, et al. – Because budesonide–formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β2-agonist (SABA) in previous studies, researchers of this investigation—which included adults with mild asthma—determined whether budesonide–formoterol used as needed was better than albuterol used to prevent exacerbations of asthma. Overall, they found that budesonide–formoterol used as needed was superior to albuterol used as needed for the prevention of asthma exacerbations in adults with mild asthma.

Methods

• This was a 52-week, randomized, open-label, parallel-group, controlled trial that involved adults with mild asthma.
• Study participants were randomized to receive either: albuterol (100 μg, two inhalations from a pressurized metered-dose inhaler as needed for asthma symptoms; albuterol group), budesonide (200 μg, one inhalation through a Turbuhaler twice daily) plus as-needed albuterol (budesonide maintenance group), or budesonide–formoterol (200 μg of budesonide and 6 μg of formoterol, one inhalation through a Turbuhaler as needed; budesonide–formoterol group).
• To measure medication use, they electronically monitored inhalers.
• The annualized rate of asthma exacerbations was the primary outcome.

Results

• The analysis included 668 of 675 randomized patients.
• In the budesonide–formoterol group, the annualized rate of exacerbation was lower than that in the albuterol group and was not significantly different from the rate in the budesonide maintenance group.
• In the budesonide–formoterol group, the number of severe exacerbations was lower than in both the albuterol group (9 vs 23; relative risk: 0.40; 95% CI: 0.18-0.86) and the budesonide maintenance group (9 vs 21; relative risk: 0.44; 95% CI: 0.20-0.96).
• The mean dose (±SD) of inhaled budesonide in the budesonide–formoterol group was 107±109 μg per day, and in the budesonide maintenance group, 222±13 μg per day.
• Reported incidence and adverse event types were consistent with those noted in previous trials and reports in clinical use.