Matthew B. Stanbrook, MD, PhD
Is biomarker- or symptom-based adjustment of inhaled corticosteroid (ICS) dose better than physician assessment–based adjustment for preventing treatment failure in adults with mild to moderate asthma?
Randomized, placebo-controlled, 3-group trial (Best Adjustment Strategy for Asthma in the Long Term [BASALT] trial). ClinicalTrials.gov NCT00495157.
Unclear allocation concealment.*
10 academic medical centers in the USA.
342 adults (mean age 35 y, 69% women) who had physician-diagnosed, mild to moderate, persistent asthma that was well- or partially controlled with low-dose ICSs; reversible airflow limitation or airway hyperresponsiveness; and ≥ 75% treatment adherence between enrollment and randomization.
Beclomethasone HFA inhaler, twice daily, with dose adjusted every 6 weeks based on exhaled nitric oxide levels, plus 2 placebo inhalers (1 used twice daily and 1 as needed) (biomarker group, n = 115); beclomethasone inhaler used only when rescue albuterol was used, plus 2 placebo inhalers used twice daily (symptom group, n = 113); or beclomethasone inhaler, twice daily, with dose adjusted every 6 weeks based on guideline-informed physician assessment, plus 2 placebo inhalers (1 used twice daily and 1 as needed) (physician group, n = 114). All groups used an albuterol inhaler as needed for asthma symptoms.
Primary outcome was first treatment failure (clinically important worsening of asthma). Other outcomes included exacerbations. The study was powered to detect a 60% reduction in treatment failure rate from 30% in the physician assessment–based adjustment group (87% power, 2-sided α = 0.025 for each of 2 main comparisons: biomarker or symptom group vs physician group).
85% (intention-to-treat analysis).
Biomarker and symptom groups did not differ from the physician group for treatment failure (Table) or asthma exacerbations (biomarker vs physician groups, 0.21 vs 0.23 events per person-y, P = 0.89; symptom vs physician groups, 0.12 vs 0.23 events per person-y, P = 0.11).
In adults with mild to moderate asthma, biomarker- or symptom-based adjustment of inhaled corticosteroid dose did not reduce treatment failure compared with physician assessment–based adjustment.
Adjustment of ICS dose based on a biomarker (BBA) or symptoms (SBA) vs physician assessment (PABA) in adults with mild to moderate asthma†
†ICS = inhaled corticosteroid; other abbreviations defined in Glossary. Event rates, RRR, and CI calculated from number of events and randomized patients reported in article.
Stanbrook MB. Physician-, biomarker-, and symptom-based adjustment of inhaled corticosteroids for asthma had similar effects. Ann Intern Med. ;158:JC6. doi: 10.7326/0003-4819-158-2-201301150-02006
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Published: Ann Intern Med. 2013;158(2):JC6.
Asthma, Pulmonary/Critical Care.
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