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

Kaharu Sumino, Leonard B. Bacharier, Juanita Taylor, Kelley Chadwick-Mansker, Vanessa Curtis, Alison Nash, Shawni Jackson-Triggs, Joseph Moen, Kenneth B. Schechtman, Jane Garbutt, Mario Castro

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47 Scopus citations


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.

Original languageEnglish
Pages (from-to)176-185.e2
JournalJournal of Allergy and Clinical Immunology: In Practice
Issue number1
StatePublished - Jan 2020


  • As-needed
  • Inhaled corticosteroids
  • Mild asthma
  • Pragmatic
  • Primary care


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