Adjustments to Inhaled Corticosteroids in Asthma

A study in adults with mild-to-moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy has demonstrated that adjustments in therapy based on biomarkers or symptoms were no better than standard physician assessment-based adjustments in preventing treatment failure. The findings of the BASALT (Best Adjustment Strategy for Asthma in the Long Term) trial were published in the Journal of the American Medical Association [2012;308(10):987-997].

The study included 342 participants with mild-to-moderate persistent asthma who were identified and recruited through cooperation with a concurrent Asthma Clinical Research Network (ACRN) trial.

Participants were randomized to receive adjustments in inhaled corticosteroid therapy based on physician assessment (n=114), biomarker (exhaled nitric oxide; n=115), or symptoms (n=113). In the physician assessment- and biomarker-based adjustment groups, inhaled corticosteroid doses were adjusted every 6 weeks. In the symptoms-based adjustment group, participants were instructed to match inhaled corticosteroids puff-per-puff with as-needed albuterol rescue. Participants received 1 of the 3 adjustment strategies over a period of 9 months.

The authors noted that physician assessment-based adjustments represent the current standard of care. The other 2 strategies were chosen because evidence exists that biomarker-based adjustments may achieve good asthma control with reduced total use of inhaled corticosteroids; and that symptoms-based adjustments result in outcomes equivalent to daily controller therapy in patients with mild asthma, according to the authors.

The primary outcome of the trial was time to first treatment failure, or a clinically important worsening of asthma, which was defined as the following: (1) asthma exacerbation (unscheduled medical contact for increased symptoms); (2) worsening based on at-home measurements (morning prebronchodilator peak expiratory flow [PEF], postbronchodilator PEF, or an increase in albuterol use of more than 8 puffs per 24 hours from baseline); or (3) worsening based on in-clinic measurements such as prebronchodilator forced expiratory volume in the first second of expiration, physician judgment, patient dissatisfaction with asthma control, or a requirement for open-label use of inhaled corticosteroids or another asthma medication.

The investigators found no significant differences in time to treatment failure, with 9-month rates of 22%, 20%, and 15% for physician assessment-based, biomarker-based, and symptom-based adjustments, respectively. Likewise, treatment failure rates were not significantly different among groups when multiple episodes of treatment failure were taken into account.

Meanwhile, mean monthly beclomethasone use was higher among participants in the physician assessment-based and biomarker-based adjustment groups, compared with the symptoms-based adjustment group (1610 mg, 1617 mg, and 832 mg, respectively). Overall, participants required less inhaled corticosteroids during the study, with approximately 40% having acceptable asthma control despite taking no beclomethasone during 1 or more follow-up visits.

Rates of asthma exacerbation (including multiple episodes) did not differ among treatment groups over the course of the study, nor did the mean proportion of treatment failures that progressed to exacerbations. In addition, measures of lung function and asthma symptoms did not differ significantly among treatment groups.

The authors emphasized that the principal finding of the trial was that the rates of treatment failure were no lower with symptoms-based adjustments (puff-per-puff inhaled corticosteroids with rescue albuterol) than with adjustments in inhaled corticosteroid use based on standard physician assessment. Likewise, adjustments in inhaled corticosteroid use based on exhaled nitric oxide did not result in lower rates of treatment failure compared with physician assessment-based adjustments.