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


      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.


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


      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.


      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.


      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)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic and Personal


      Subscribe to The Journal of Allergy and Clinical Immunology: In Practice
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Global Initiative for Asthma
        Global strategy for asthma management and prevention. 2018.
        (Available from:)
        Date accessed: June 1, 2019
        • National Asthma Education and Prevention Program
        Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma—Summary Report 2007.
        J Allergy Clin Immunol. 2007; 120: S94-S138
        • Bender B.G.
        Nonadherence to asthma treatment: getting unstuck.
        J Allergy Clin Immunol Pract. 2016; 4: 849-851
        • Zhang L.
        • Prietsch S.O.
        • Ducharme F.M.
        Inhaled corticosteroids in children with persistent asthma: effects on growth.
        Evid Based Child Health. 2014; 9: 829-930
        • Weatherall M.
        • Clay J.
        • James K.
        • Perrin K.
        • Shirtcliffe P.
        • Beasley R.
        Dose-response relationship of inhaled corticosteroids and cataracts: a systematic review and meta-analysis.
        Respirology. 2009; 14: 983-990
        • Menckeberg T.T.
        • Bouvy M.L.
        • Bracke M.
        • Kaptein A.A.
        • Leufkens H.G.
        • Raaijmakers J.A.
        • et al.
        Beliefs about medicines predict refill adherence to inhaled corticosteroids.
        J Psychosom Res. 2008; 64: 47-54
        • Laster N.
        • Holsey C.N.
        • Shendell D.G.
        • McCarty F.A.
        • Celano M.
        Barriers to asthma management among urban families: caregiver and child perspectives.
        J Asthma. 2009; 46: 731-739
        • Dy T.
        • Lewis E.M.
        • Murugan V.
        • Gehlert S.
        • Taylor J.
        • Garbutt J.
        • et al.
        Caregiver and pediatric provider perspectives on symptom-based inhaled corticosteroid therapy in asthma.
        Respir Med. 2018; 137: 201-205
        • Wu A.C.
        • Li L.
        • Fung V.
        • Kharbanda E.O.
        • Larkin E.K.
        • Butler M.G.
        • et al.
        Mismatching among guidelines, providers, and parents on controller medication use in children with asthma.
        J Allergy Clin Immunol Pract. 2016; 4: 910-916
        • Sawicki G.S.
        • Smith L.
        • Bokhour B.
        • Gay C.
        • Hohman K.H.
        • Galbraith A.A.
        • et al.
        Periodic use of inhaled steroids in children with mild persistent asthma: what are pediatricians recommending?.
        Clin Pediatr (Phila). 2008; 47: 446-451
        • Papi A.
        • Canonica G.W.
        • Maestrelli P.
        • Paggiaro P.
        • Olivieri D.
        • Pozzi E.
        • et al.
        Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma.
        N Engl J Med. 2007; 356: 2040-2052
        • Calhoun W.J.
        • Ameredes B.T.
        • King T.S.
        • Icitovic N.
        • Bleecker E.R.
        • Castro M.
        • et al.
        Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial.
        JAMA. 2012; 308: 987-997
        • Martinez F.D.
        • Chinchilli V.M.
        • Morgan W.J.
        • Boehmer S.J.
        • Lemanske Jr., R.F.
        • Mauger D.T.
        • et al.
        Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial.
        Lancet. 2011; 377: 650-657
        • Global Initiative for Asthma
        Global strategy for asthma management and prevention 2019.
        (Available from:)
        Date accessed: June 1, 2019
        • O’Byrne P.M.
        • FitzGerald J.M.
        • Bateman E.D.
        • Barnes P.J.
        • Zhong N.
        • Keen C.
        • et al.
        Inhaled combined budesonide-formoterol as needed in mild asthma.
        N Engl J Med. 2018; 378: 1865-1876
        • Bateman E.D.
        • Reddel H.K.
        • O’Byrne P.M.
        • Barnes P.J.
        • Zhong N.
        • Keen C.
        • et al.
        As-needed budesonide-formoterol versus maintenance budesonide in mild asthma.
        N Engl J Med. 2018; 378: 1877-1887
        • Galbraith A.A.
        • Smith L.A.
        • Bokhour B.
        • Miroshnik I.L.
        • Sawicki G.S.
        • Glauber J.H.
        • et al.
        Asthma care quality for children with minority-serving providers.
        Arch Pediatr Adolesc Med. 2010; 164: 38-45
        • Wisnivesky J.P.
        • Lorenzo J.
        • Lyn-Cook R.
        • Newman T.
        • Aponte A.
        • Kiefer E.
        • et al.
        Barriers to adherence to asthma management guidelines among inner-city primary care providers.
        Ann Allergy Asthma Immunol. 2008; 101: 264-270
        • Flores G.
        • Snowden-Bridon C.
        • Torres S.
        • Perez R.
        • Walter T.
        • Brotanek J.
        • et al.
        Urban minority children with asthma: substantial morbidity, compromised quality and access to specialists, and the importance of poverty and specialty care.
        J Asthma. 2009; 46: 392-398
        • George M.
        Health beliefs, treatment preferences and complementary and alternative medicine for asthma, smoking and lung cancer self-management in diverse Black communities.
        Patient Educ Couns. 2012; 89: 489-500
        • Naimi D.R.
        • Freedman T.G.
        • Ginsburg K.R.
        • Bogen D.
        • Rand C.S.
        • Apter A.J.
        Adolescents and asthma: why bother with our meds?.
        J Allergy Clin Immunol. 2009; 123: 1335-1341
        • Nathan R.A.
        • Sorkness C.A.
        • Kosinski M.
        • Schatz M.
        • Li J.T.
        • Marcus P.
        • et al.
        Development of the asthma control test: a survey for assessing asthma control.
        J Allergy Clin Immunol. 2004; 113: 59-65
        • Liu A.H.
        • Zeiger R.
        • Sorkness C.
        • Mahr T.
        • Ostrom N.
        • Burgess S.
        • et al.
        Development and cross-sectional validation of the Childhood Asthma Control Test.
        J Allergy Clin Immunol. 2007; 119: 817-825
        • Schatz M.
        • Sorkness C.A.
        • Li J.T.
        • Marcus P.
        • Murray J.J.
        • Nathan R.A.
        • et al.
        Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists.
        J Allergy Clin Immunol. 2006; 117: 549-556
        • Asmussen L.
        • Olson L.M.
        • Grant E.N.
        • Fagan J.
        • Weiss K.B.
        Reliability and validity of the Children’s Health Survey for Asthma.
        Pediatrics. 1999; 104: e71
        • Radecki L.
        • Olson L.
        • Frintner M.P.
        • Weiss K.
        Reliability and validity of the Children’s Health Survey for Asthma-Child version.
        Pediatr Asthma Allergy Immunol. 2008; 21: 89-98
        • Schatz M.
        • Kosinski M.
        • Yarlas A.S.
        • Hanlon J.
        • Watson M.E.
        • Jhingran P.
        The minimally important difference of the Asthma Control Test.
        J Allergy Clin Immunol. 2009; 124: 719-723.e1
      1. Standardization of Spirometry, 1994 Update. American Thoracic Society.
        Am J Respir Crit Care Med. 1995; 152: 1107-1136
        • Bime C.
        • Gerald J.K.
        • Wei C.Y.
        • Holbrook J.T.
        • Teague W.G.
        • Wise R.A.
        • et al.
        Measurement characteristics of the childhood Asthma-Control Test and a shortened, child-only version.
        NPJ Prim Care Respir Med. 2016; 26: 16075
        • Conn K.M.
        • Halterman J.S.
        • Lynch K.
        • Cabana M.D.
        The impact of parents’ medication beliefs on asthma management.
        Pediatrics. 2007; 120: e521-e526
        • George M.
        • Topaz M.
        • Rand C.
        • Sommers M.L.S.
        • Glanz K.
        • Pantalon M.V.
        • et al.
        Inhaled corticosteroid beliefs, complementary and alternative medicine, and uncontrolled asthma in urban minority adults.
        J Allergy Clin Immunol. 2014; 134: 1252-1259
        • Quon B.S.
        • Fitzgerald J.M.
        • Lemiere C.
        • Shahidi N.
        • Ducharme F.M.
        Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children.
        Cochrane Database Syst Rev. 2010; : CD007524
        • Jackson D.J.
        • Bacharier L.B.
        • Mauger D.T.
        • Boehmer S.
        • Beigelman A.
        • Chmiel J.F.
        • et al.
        Quintupling inhaled glucocorticoids to prevent childhood asthma exacerbations.
        N Engl J Med. 2018; 378: 891-901
        • Garbutt J.M.
        • Yan Y.
        • Highstein G.
        • Strunk R.C.
        A cluster-randomized trial shows telephone peer coaching for parents reduces children’s asthma morbidity.
        J Allergy Clin Immunol. 2015; 135: 1163-1170.e1-1170.e2
        • Dusser D.
        • Montani D.
        • Chanez P.
        • de Blic J.
        • Delacourt C.
        • Deschildre A.
        • et al.
        Mild asthma: an expert review on epidemiology, clinical characteristics and treatment recommendations.
        Allergy. 2007; 62: 591-604

      Linked Article

      • Optimal asthma control in African American children with asthma
        The Journal of Allergy and Clinical Immunology: In PracticeVol. 8Issue 6
        • Preview
          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.
        • Full-Text
        • PDF