Three Approaches Equal for Asthma Med Adjustment

When it comes to adjusting the dose of inhaled corticosteroids for better asthma control, periodic physician assessment was as good a gauge as using a biomarker or day-to-day symptom occurrence, researchers found.

In a randomized, controlled trial, there were no significant differences in time to treatment failure for any of those three options in adults with asthma controlled with low-dose inhaled corticosteroid therapy, reported William Calhoun, MD, of the University of Texas Medical Branch in Galveston, and colleagues in the Sept. 12 issue of the Journal of the American Medical Association.

"Adjusting inhaled corticosteroid doses based on symptoms was just as effective as the NIH guidelines [for physicians] and just as effective as with biomarkers [of] exhaled nitric oxide," Calhoun told The JAMA Report.

Asthma patients periodically require adjustments in inhaled corticosteroid therapy, which have largely been based on guidelines recommending clinician assessment of the patient's needs.

But it's been unclear whether adjusting based on specific patient symptoms or on a biomarker of exhaled nitric oxide could be superior to clinician assessment.

So the researchers conducted the Best Adjustment Strategy for Asthma in the Long Term (BASALT) trial of 342 patients with mild-to-moderate asthma between 2007 and 2010.

Patients were randomized to one of three groups for 36 weeks:

• Standard care, with clinicians assessing rescue albuterol use and pulmonary function at 6-week intervals to determine dose adjustment
• Biomarker-based adjustment using exhaled nitric oxide every 6 weeks
• Symptom-based adjustment in which patients took two puffs of low-dose beclomethasone (40 mcg/puff) every time they took 2 puffs of albuterol for symptom relief

The primary outcome was disease worsening as measured by time to treatment failure.

The researchers found no significant differences in the primary outcome, with failure rates of 22% for physician assessment, 20% for biomarker-based adjustment, and 15% for symptom-based adjustment.

Even when multiple episodes of treatment failure were included, treatment failure rates were not different among groups (P=0.21):

• 0.43 events/person-years for physician-based assessment (97.5% CI 0.23 to 0.64)
• 0.27 events/person-years for biomarker-based adjustment (97.5% CI 0.14 to 0.39)
• 0.25 events/person-years for symptom-based adjustment (97.5% CI 0.10 to 0.39)

Neither of the alternate strategies were significantly different from standard physician assessment, the researchers reported, and asthma exacerbation rates didn't differ either.

While airway responsiveness worsened in the physician-based assessment group compared with the biomarker-based assessment (P<.0006), it did not differ when the symptom-based assessment group was compared with the other two groups.

Also, measures of lung function and asthma symptoms were not significantly different among the groups.

Few days were lost from school or work, although the likelihood of missing days was significantly higher for the biomarker-based assessment group than for the standard care or symptom-based assessment groups (OR 2.0, 95% CI 1.1 to 3.8, P=0.01 and OR 4.3, 95% CI 1.9 to 9.6, P<0.001).

Predictors of time to treatment failure included race (P=0.001) and albuterol reversibility (P=0.004), the researchers added.

The study was limited by its small sample size, they noted, and findings in highly controlled clinical trials may not translate directly to clinical practice.

Still, they concluded that neither the symptom-based nor the biomarker-based assessment "was superior to the standard strategy for the outcome of treatment failure."

In an accompanying editorial, George O'Connor, MD, of Boston University, and Joan Reibman, MD, of New York University, wrote that on the basis of this trial and previous trials, there is "no compelling rationale to alter the current approach to inhaled corticosteroid dosing for mild or mild-to-moderate, persistent asthma."

They added that the study also makes it "difficult to justify additional healthcare expenditures" for routine nitric oxide monitoring of asthma patients, which has been an area of controversy.

They noted that further research "including adequately powered equivalence trials, could change this in the future."

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Kristina Fiore

Staff Writer

Kristina Fiore joined MedPage Today after earning a degree in science, health, and environmental reporting from NYU. She's had bylines in newspapers and trade and consumer magazines including Newsday, ABC News, New Jersey Monthly, and Earth Magazine. At MedPage Today, she reports with a focus on diabetes, nutrition, and addiction medicine.

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