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A Pragmatic Trial of Symptom-Based Inhaled Corticosteroid Use in African-American Children with Mild Asthma

      Background

      Symptom-based adjustment (SBA) of inhaled corticosteroids may be an alternative patient-centered approach in which day-to-day inhaled corticosteroid use is adjusted by symptoms and short-acting β-agonist need.

      Objective

      To evaluate the effectiveness of SBA in the primary care setting.

      Methods

      We conducted a randomized, open-label, pragmatic equivalence trial in African-American children (6-17 years old) with mild asthma managed by 12 primary care providers (PCPs). A total of 206 participants were randomized to SBA (as-needed beclomethasone 80 μg with rescue short-acting β-agonist) or provider-based guideline-directed adjustment (PBA): maintenance beclomethasone 80 μg/d (6-11 years old), 160 μg/d (12-17 years old), with subsequent guideline-based dose adjustment by PCPs. PCPs implemented both treatment assignments, with outcomes measured by blinded staff. All participants received symptom recognition and albuterol use education from peer educators. Primary outcome was change in asthma control (measured by Asthma Control Test [ACT]/childhood ACT [cACT]) over 12 months.

      Results

      Participants had adequately controlled asthma (mean ACT or cACT score = 21.6 ± 2.8) at baseline. After 1 year, there was no significant between-group difference in change in ACT scores (SBA − PBA): ACT: −0.88 (95% CI, −2.19 to 0.42), cACT: −0.73 (−2.09 to 0.62), or combined ACT and cACT (P = .10), and was within the predefined statistical clinical equivalence. The proportion with an exacerbation and measures of lung function were similar between groups. Compared with PBA, SBA led to less beclomethasone use (SBA: 526 μg/mo [95% CI, 412-639 μg] vs PBA: 1961 μg/mo [95% CI, 1681-2241]; P < .0001). More parents in the SBA arm felt they were managing their child's asthma.

      Conclusions

      SBA in African-American children with mild asthma was similar to PBA in asthma control and events when implemented by PCPs with lower inhaled corticosteroid exposure.

      Key words

      Abbreviations used:

      ACT (Asthma Control Test), cACT (Childhood Asthma Control Test), ICS (Inhaled corticosteroids), LABA (Long-acting β-agonist), PBA (Provider-based guideline-directed adjustment), PCP (Primary care provider), SABA (Short-acting β-agonist), SBA (Symptom-based adjustment)
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      Linked Article

      • Optimal asthma control in African American children with asthma
        The Journal of Allergy and Clinical Immunology: In PracticeVol. 8Issue 6
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          First, we congratulate Sumino et al1 for taking on the challenge of conducting a difficult pragmatic trial in children with asthma.1 Their study demonstrated no difference in asthma control or exacerbations between using maintenance and on-demand symptom-driven use of inhaled corticosteroid (ICS), albeit in children who had prior well-controlled asthma. In reality, few children or their caregivers are going to bother with having to take ICS and short-acting β-agonist (SABA) on demand via separate inhalers, especially via a holding chamber, which is cumbersome and difficult to use correctly.
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