Beta AGonist in Mild Asthma Study (BAGS)
In patients with mild asthma, whose only asthma treatment is inhaled ß-agonists, addition of regular inhaled ß-agonist treatment to treatment on an "as needed only" basis will result in no effect on asthma control.
Patients with mild asthma, and with an FEV1 ³ 70% predicted using ß-agonists as their sole therapy, were recruited and followed for a 6-week single-blind run-in period during which they took a coded placebo inhaler, 2 puffs qid. A Chronolog TM recording device was used to assure compliance and all patients were provided "open label" albuterol for rescue use. If, after the run-in period, patients were compliant and still met entry criteria, they were randomized to receive either albuterol or placebo, 2 puffs qid via the Chronolog TM during a 16-week double-blind treatment period, which was followed by a 4-week "run-out" period during which patients received single-blind QID placebo. The primary outcome variable was AM peak expiratory flow (PEF) (measured using a Mini-Wright TM peak flow meter), with multiple secondary outcome variables including PM PEF, AM-PM PEF variability, asthma symptom scores, rescue albuterol use, FEV1, including response to albuterol, methacholine PC20, quality of life, asthma exacerbations, and treatment failures.
Enrollment occurred December 1994 through July 1995, with the last subject visits occurring in February 1996. Of the 319 subjects recruited, 255 (33% minority, 56% female) were eligible for randomization to receive double-blind treatment (126 in the regular use group and 129 in the as-needed group). Groups were well matched for all inclusion criteria and 230 subjects completed the trial. Compliance with inhaled medication was > 80%, and more than 99% of the scheduled clinic visits were kept. Albuterol use averaged 9.3 puffs/day in the regular use group, and 1.6 puffs/day in the as-needed group. A total of 28 significant asthma exacerbations occurred in 12 regular use subjects and 11 as-needed subjects and a total of 13 subjects were assigned treatment failure status (7 regular use and 6 as-needed subjects). There were three ER visits but no hospitalizations or deaths due to asthma. No between-group differences were noted with respect to changes over time for the primary outcome parameter (AM PEF). The major publication appeared in NEJM:
Drazen JM, Israel E, Boushey HA, Chinchilli VM, Fahy JV, Fish JE, Lazarus SC, Lemanske RF, Martin RJ, Peters SP, Sorkness C, Szefler SJ. Comparison of regularly with as-needed use of albuterol in mild asthma. New England Journal of Medicine 1996; 335:841-847.