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

doi:10.1016/j.jaip.2019.06.030

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

J Allergy Clin Immunol Pract. 2020 Jan;8(1):176-185.e2. doi: 10.1016/j.jaip.2019.06.030. Epub 2019 Jul 30.

Affiliations

¹ Department of Medicine, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, Saint Louis, Mo. Electronic address: ksumino@wustl.edu.
² Department of Pediatrics, Washington University School of Medicine, Saint Louis, Mo; Division of Allergy, Immunology and Pulmonary Medicine, Washington University School of Medicine, Saint Louis, Mo.
³ Department of Medicine, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, Saint Louis, Mo.
⁴ Department of Pediatrics, Washington University School of Medicine, Saint Louis, Mo.
⁵ Department of Medicine, Division of Biostatistics, Washington University School of Medicine, Saint Louis, Mo.
⁶ Department of Pediatrics, Washington University School of Medicine, Saint Louis, Mo; Department of Medicine, Division of General Medical Sciences, Washington University School of Medicine, Saint Louis, Mo.

PMID: 31371165
DOI: 10.1016/j.jaip.2019.06.030

Abstract

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.

Keywords: As-needed; Inhaled corticosteroids; Mild asthma; Pragmatic; Primary care.

Publication types

Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Inhalation
Adolescent
Adrenal Cortex Hormones / therapeutic use
Anti-Asthmatic Agents* / therapeutic use
Asthma* / drug therapy
Asthma* / epidemiology
Black or African American
Child
Humans

Substances

Adrenal Cortex Hormones
Anti-Asthmatic Agents